Drug Information Update · 2019-05-29 · NEW INDICATIONS (EXISTING DRUGS) BENLYSTA® April 26, 2019 GSK announced today that the US Food and Drug Administration (FDA) has approved,

Page 0 of 126

Drug Information Update May 2019

Page 1 www.performrx.com

200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved

TABLE OF CONTENTS

NEWLY AVAILABLE GENERICS ................................................................. 2

NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS ............................... 3

NEW INDICATIONS (EXISTING DRUGS) .................................................... 4

FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS .............................. 6

STUDIES AND RECENT TOPICS ............................................................... 22

RECALLS ................................................................................................ 25

CURRENT DRUG SHORTAGES ................................................................ 57



NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE

FORM GENERIC

MANUFACTURER BRAND NAME

SOLIFENACIN SUCCINATE 5, 10 MG TABLET ASTELLAS

PHARMACEUTICALS VESICARE

VALRUBICIN 40 MG/ML VIAL ENDO

PHARMACEUTICALS, INC.

VALSTAR

CEFIXIME 400 MG CAPSULE

LUPIN PHARMACEUTICALS,

ASCEND LABORATORIES

SUPRAX

PENICILLAMINE 250 MG CAPSULE AMERIGEN

PHARMACEUTICALS CUPRIMINE

ERLOTINIB HCL 25 MG, 100 MG, 150 MG

TABLET TEVA TARCEVA

LOTEPREDNOL ETABONATE 0.5 % SOLUTION DROPS AKORN INC. LOTEMAX

MIFEPRISTONE 200 MG TABLET GENBIOPRO, INC. MIFEPREX

BOSENTAN 62.5 MG, 125 MG TABLET ZYDUS

PHARMACEUTICALS TRACLEER

MESALAMINE 400 MG DELAYED RELEASE

(DR) CAPSULE TEVA DELZICOL



NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

ANTIPSORIATIC AGENTS, SYSTEMIC

SKYRIZI KIT RISANKIZUMAB-

RZAA

75 MG/0.83 ML SUBQ SYRINGE, 150 MG/1.66 ML SUBQ

SYRINGE KIT (2 SYRINGES)

NEW ENTITY

ANTIPSORIATICS AGENTS

DUOBRII HALOBETASOL

PROPIONATE/TAZAROTENE

0.01%-0.045% LOTION

NEW COMBINATION

CYSTIC FIB-TRANSMEMB CONDUCT.REG.(CFTR)PO

TENTIATOR KALYDECO IVACAFTOR

25 MG GRANULES PACKET

NEW STRENGTH

DRUGS TO TREAT MOVEMENT DISORDERS

INGREZZA INITIATION PACK

VALBENAZINE TOSYLATE

40 MG (7) – 80 MG (21) CAPSULES

INITIATION PACK

TETRACYCLINE ANTIBIOTICS

DOXYCYCLINE HYCLATE

DOXYCYCLINE HYCLATE

80 MG DR TABLET NEW

STRENGTH

TX FOR ATTENTION DEFICIT-HYPERACT

(ADHD)/ NARCOLEPSY

JORNAY PM METHYL-

PHENIDATE HCL

20 MG, 40 MG, 60 MG, 80 MG, 100 MG CAPSULE: DR,

ER & SP

NEW DOSAGE FORM

PROTEIN STABILIZERS VYNDAQEL TAFAMIDIS

MEGLUMINE 20 MG CAPSULE NEW ENTITY

ANTINEOPLASTIC SYSTEMIC ENZYME

INHIBITORS ZYKADIA CERITINIB 150 MG TABLET

NEW DOSAGE FORM

TOPICAL ANTI-INFLAMMATORY NSAID-

LOCAL ANESTHETIC DICLOVIX

DICLOFENAC/ LIDO/ME-

SAL/CAMPHOR 1.5%-2.5%-4% KIT

RX TOPICAL SOLUTION + OTC PATCH

ANTISERA CUTAQUIG IMMUNOGLOBU

LIN G (IGG) – HIPP/MALTOSE

16.5% SUBQ VIAL

NEW FORMULATION

, NEW STRENGTH



NEW INDICATIONS (EXISTING DRUGS)

BENLYSTA®

April 26, 2019

GSK announced today that the US Food and Drug Administration (FDA) has approved, under priority

review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator

(BLyS)-specific inhibitor, in children with lupus from as young as five years of age.

Source: GSK

EYLEA® May 13, 2019 Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness. Source: Regeneron Pharmaceuticals, Inc. CYRAMZA® May 13, 2019 Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib. Concurrent with this FDA approval – the fifth for CYRAMZA – the FDA has also removed the boxed warning from the CYRAMZA labeling. Source: Eli Lilly and Company BAVENCIO® and INLYTA® May 14, 2019 EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. announced today that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC. The approval of BAVENCIO in combination with INLYTA was based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months in the intent-to-treat (ITT) patient population (HR: 0.69 [95% CI: 0.56–0.84]; 2-sided p-value=0.0002; median PFS for BAVENCIO in combination with INLYTA: 13.8 months [95% CI: 11.1-NE]; sunitinib: 8.4 months [95% CI: 6.9-11.1]). The ITT population included patients



regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups (favorable 21%, intermediate 62% and poor 16%). Source: EMD Serono



FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP by Torrent Pharmaceuticals - Recall: Due to Detection of Trace Amounts of an Unexpected Impurity [Posted 04/18/2019] ISSUE: Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan Potassium Tablets, USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA. Source: U.S. Food and Drug Administration (FDA) Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling [Posted 04/19/2019] Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h. This transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, MN. Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life threatening, or fatal respiratory depression. Groups at potential increased risk could include first time recipients of such patches, children, and the elderly. To date, Alvogen Inc. has not received any reports of adverse events related to this issue. The product is indicated for the management of pain in opioid tolerant patients and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lots include: Lot 180060 of Fentanyl Transdermal System, 12 mcg/h, expiration date 05/2020. Lot 180073 of Fentanyl Transdermal System, 12 mcg/h, expiration date 06/2020. The mislabeled product is packaged in a 12 mcg/h primary carton. These lots of Fentanyl Transdermal System were distributed Nationwide to the pharmacy level.



Alvogen Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Pharmacies are requested not to dispense any product subject to this recall. Patients that have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement. Questions regarding this recall should be directed to Alvogen Customer Complaints by calling 866-770-3024 or sending an e-mail to [email protected] from Monday to Friday from 9:00 am to 5:00 pm EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Source: U.S. Food and Drug Administration (FDA)

Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium

Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric

acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredient (API)

[Posted 04/24/2019]

Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots

Losartan Tablets USP 50mg to include one additional lot. This recall was prompted due to Torrent

Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the

detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process

impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited,

(API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events

related to this recall.

Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive

heart failure and is packaged in 30ct bottles. The identifying NDC number associated with Legacy’s

product is as follows:

Losartan Potassium, USP, 50mg NDC 68645-494-54



The affected Losartan Potassium includes 4 repackaged lots numbers (3 initial repackaged lot and 1

expanded repackaged lot) which are listed below:

LEGACY NDC# Name and Strength Count Legacy Lot # Expiry

68645-494-54 Losartan Potassium Tablets USP 50 mg

30 180190 10/2020


30 180191 10/2020


30 181597 02/2021


30 181598 02/2021

The product can be identified by checking the product name and repackaged lot number on the bottle

containing these products.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is

notifying its distributors and customers in writing and is arranging/assisting for return of all recalled

products to Inmar Pharmaceutical Services. Instructions for returning recalled products are provided in

the recall letter.

Consumers with questions regarding this recall can contact Inmar at 1-877-538-8443, Monday – Friday,

9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have that may

be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online: www.fda.gov/medwatch/report.htm

Regular mail or fax: download form or call 1-800-332-1088 to request a reporting form, then complete the return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S> Food and Drug Administration Source: U.S. Food and Drug Administration (FDA) Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply [Posted 04/26/2019] Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). This recall is due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.

http://www.fda.gov/medwatch/report.htm



Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The lots were sold exclusively to Golden State Medical Supply of Camarillo, California. Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90, and 1000 tablets. To date, Teva has not received any reports of adverse events related to the lots being recalled. No other Teva Losartan Potassium finished drug products have been identified, in the United States, containing API above the interim specification levels set for NMBA. The affected Losartan Potassium tablets being recalled are described as:

• Losartan Potassium tablets, USP 25 mg, are light-green, film-coated, teardrop-shaped biconvex tablet with “LK 25” on one side and ">" on the other side.

• Losartan Potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side.

Teva promptly notified Golden State Medical Supply of the presence of the impurity in Hetero’s API and Teva will recall thirty-five (35) lots of bulk Losartan Potassium tablets sold to that company. The tablets, which have been packaged and sold by Golden State Medical Supply, will be recalled from their customers and patients. Distributors and retailers that have product being recalled should immediately stop distribution, quarantine all remaining product in their control, and return the recalled product per the instructions given to them by Golden State Medical Supply. Patients taking Losartan Potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without any alternative treatment. For full drug product information, please refer to the full prescribing information for Losartan Potassium tablets USP. Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled under the Golden State Medical Supply label should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at [email protected]. Adverse reactions or other problems experienced with the use of these products should also be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm. • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-

1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-1088.

Patient safety and product quality are critical to Teva. As always, Teva and Golden State Medical Supply will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation. Lots Under Voluntary Recall The finished product lots that are included in this voluntary recall and listed below were sold by Teva in bulk containers. The tablets were repackaged for further distribution by Golden State Medical Supply

mailto:[email protected]



under its product label. The bulk tablet lots were repackaged into 44 finished products lots for further distribution by Golden State Medical Supply under its product label.

GSMS FG NDCs GSMS FG NDC Description

GSMS FG Product Lots GSMS FG Expiration Dates

60429-318-90 Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle

GS014045 06/2019


GS014305 06/2019

60429-318-10 Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle

GS014054 06/2019


GS014044 06/2019


GS014817 06/2019


GS015172 06/2019


GS015204 06/2019


GS016338 12/2019


GS016341 01/2020


GS016342 01/2020


GS016343 01/2020


GS016344 01/2020


GS016345 01/2020

60429-318-90 Losartan Potassium, Tablets, USP, 100 mg,

GS016535 01/2020



90 Count Bottle


GS016524 01/2020


GS016539 01/2020


GS016969 01/2020


GS016973 01/2020


GS017337 01/2020


GS017384 02/2020


GS017385 01/2020


GS017539 01/2020


GS017540 01/2020


GS017543 01/2020


GS017542 01/2020


GS018524 02/2020


GS017984 02/2020


GS017985 02/2020


GS017986 02/2020




GS018263 02/2020


GS018264 02/2020


GS017634 02/2020


GS017653 02/2020


GS017980 02/2020


GS017981 02/2020


GS018265 02/2020


GS016726 02/2020


GS016958 02/2020


GS017045 02/2020


GS017276 02/2020


GS017341 02/2020


GS018318 02/2020


GS017342 02/2020


GS017808 02/2020



Note – “GSMS FG” refers to Golden State Medical Supply Finished Goods. Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication:

Contact Inmar at 877-789-2065 (Hours of operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: [email protected].

Inmar will provide the materials needed to return their medication and instructions for reimbursement.

Customers of Golden State Medical Supply may: o Call: (800) 284-8633, ext. 215 o Fax: (805) 437-7582 o Email: [email protected]

Product labels associated with the lots being recalled will be posted to the FDA website under Recalls and Alerts. Source: U.S. Food and Drug Administration (FDA) AmEx Pharmacy Issues Voluntary Nationwide Recall for one Lot of Bevacizumab 1.25mg/0.05mL 31 G Syringe Due to Reported Defective Delivery System [Posted 04/29/2019] AmEx Pharmacy is voluntarily recalling one Lot of Bevacizumab 1.25mg/0.05mL 31G Injectable to the consumer/user level. The Monoject Syringe of this product may become difficult to express, and when additional force is applied, while the needle is in the eye, may cause injury to the patient. The additional force needed to express the drug product could potentially result in damage to the eye while the needle is in the eye. To date, AmEx Pharmacy has received three reports associated with the Lot being recalled as either being difficult to express, two of which, resulted in an Adverse Drug Event. The product is used for Wet Age-related Macular Degeneration and Diabetic Retinopathy. It is individually wrapped and labeled in a Tyvek pouch which is then placed in a labeled amber bag to protect from light. The affected Lot of Bevacizumab 1.25 mg/0.05 mL Injectable is 190212AB, BUD 5/13/2019. The product can be identified by referencing the Lot number 190212AB, which prominently appears on all labeling. This specific Lot was distributed nationwide to ophthalmologist clinics in the following states: PA, IL, TX, WI, KS, TN, IN, & AZ. AmEx Pharmacy is notifying its consignees by telephone and overnight mail and is arranging for return/replacement of all recalled product. Administering physicians that have product which is being recalled should stop use, remove from inventory and return to AmEx Pharmacy. Consumers with questions regarding this recall can contact AmEx Pharmacy at (800)644-9431 or by email at [email protected] during normal business hours Monday through Friday 9:00am-6:00pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to being administered this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the

mailto:[email protected]



FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online: www.fda.gov/medwatch/report.htm

Regular mail or fax: download form or call 1-800-332-1088 to request a reporting form, then complete the return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Source: U.S. Food and Drug Administration (FDA)

Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake

[Posted 4/30/2019]

The FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with than other prescription medicines used for sleep.

Lunesta (eszopiclone)

Sonata (zaleplon)

Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist (zolpidem)

Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.

If patients experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine you should:

Stop taking your insomnia medicine.

Contact your health care professional right away if you.

Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Healthcare Professionals should advise all patients that:

Although rare, the behaviors caused by these medicines have led to serious injuries or death.

To discontinue taking these medicines if they experience an episode of complex sleep behavior.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

o Complete and submit the report Online: www.fda.gov/MedWatch/report o Download form or call 1-800-332-1088 to request a reporting form, then complete and

return to the address on the form, or submit by fax to 1-800-FDA-0178


http://www.fda.gov/medwatch/report.htm



Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance

[Posted 5/01/2019]

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis (serious condition resulting from the presence of harmful microorganisms in the blood and the body’s response to their presence, potentially leading to shock and death). The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue.

Ketorolac Tromethamine Injection, USP, is a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level.

The product is supplied in 2 ml glass tubular vials. The lot number being recalled was distributed to hospitals, wholesalers and distributors nationwide from January – March 2019.

Product Lot Number Expiration Date NDC Number Distribution Dates

Ketorolac Tromethamine Injection, USP 60 mg per 2 mL (30 mg per 1 mL)

M813513 Feb-2020 25021-701-02 January - March 2019

Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Consumers/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com Customers or consumers with any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F, 8am-7pm CST. Healthcare workers who have medical questions about Ketorolac Tromethamine Injection, USP, may contact Medical Affairs (866-625-1618,



Option 3) M-F, 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-

1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection, USP Due to the Presence of a Glass Fragment Observed in One Vial of Reconstituted Product

[Posted 05/01/2019]

Company Announcement Endo International plc, announced today that one of its operating companies, Par Pharmaceutical, Inc., is voluntarily recalling one lot of Mycophenolate Mofetil for Injection, USP to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, Par Pharmaceutical, Inc. has not received any reports of adverse events related to this recall.

Mycophenolate Mofetil for Injection, USP is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate Mofetil for Injection, USP should be used concomitantly with cyclosporine and corticosteroids. The affected Mycophenolate Mofetil for Injection, USP includes lot AD812, expiry 09/2020. The product, manufactured for Par Pharmaceutical, Inc. by Gland Pharma Limited, is packaged in cartons of 4 single use vials with NDC 42023-172-04. Mycophenolate Mofetil for Injection, USP, lot AD812 was distributed nationwide in the U.S. to wholesale distribution locations between January 23, 2019, and February 11, 2019.

Vials from the affected lot bear this label:

Par Pharmaceutical, Inc. is providing written notification to national wholesale accounts and direct customer locations that have received the affected lot and is arranging for return of all recalled product through Inmar, Inc. Wholesale distributors, retail pharmacies, and hospital pharmacies that have the product being recalled should immediately stop further distribution and use of vials from Lot AD812 and return any unused product by following the instructions below:

• Please contact Inmar, Inc. either by phone at 1-800-967-5952, extension 1 (Monday through Friday between 9 am and 5 pm ET), or by email at [email protected] to obtain return authorization labels and return shipping instructions.



Upon contacting Inmar, Inc. please be prepared to provide proof of purchase to receive reimbursement for returned product.

Wholesalers, retailers, pharmacies, and consumers with questions regarding this recall can contact Inmar, Inc. either by phone at 1-800-967-5952, extension 1 (Monday through Friday between 9 am to 5 pm ET), or by email at [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178



Vivimed Life Sciences Pvt Ltd Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP Due to the Detection of Trace Amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Impurity

[Posted 05/03/2019]

Company Announcement Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level due to the detection of an N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer) that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.

This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall.

Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage).

The identifying NDC #s associated with Heritage distributed product are as follows: Losartan Tablets 25 mg: 90- count: NDC 23155-644-09, Losartan Tablets 50 mg: 90- count: NDC 23155-645-09; 1000-count: NDC 23155-645-10, Losartan Tablets 100 mg: 90-count- NDC 23155-646-09 1000-count: NDC 23155-646-10.



Product Name Lot Number Pack Expiry Date Distributed by

Losartan Potassium Tablets USP, 25 mg

CLO17006A 90’s Nov 2019 HERITAGE


CLO17007A 1000's Nov 2019 HERITAGE






CLO17009B 90's Nov 2019 HERITAGE








CLO17014A 1000's Dec 2019 HERITAGE




CLO17015A 1000's Jan 2020 HERITAGE










CLO18002B 1000's Jan 2020 HERITAGE


CLO18020A 90's Apr 2020 HERITAGE









Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Inmar is notifying distributors and other customers by recall notification and arranging for return of recalled product of Losartan Potassium Tablets from the above lots.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product. Pharmacies and healthcare facilities that have the product being recalled from above listed lots should stop using and dispensing the product immediately. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers with questions regarding this recall can contact Vivimed C/o Inmar at 1-877-861-3811 Monday – Friday, 9am – 5pm EST.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax.

• Complete and submit the report Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

• Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/medwatch-safety-alerts-human-medical-products or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.



Novartis Issues Voluntary Nationwide Recall of Promacta® 12.5 mg for Oral Suspension Due to Potential Peanut Contamination [Posted 05/11/2019] Company Announcement Novartis today announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site. Promacta tablets in 12.5 mg, 25 mg, 50 mg and 75 mg strengths are not impacted by this recall and are not manufactured in the same facility. Peanut is a known food allergen. Potential cross contamination with peanut flour, even in small traces, can lead to hypersensitivity reaction in a population of patients with an unknown or known sensitivity to peanut antigen, including a medically significant anaphylactic reaction, which can be fatal. To date, Novartis has not received any reports or adverse events for this recall.



Promacta 12.5 mg for oral suspension is indicated for the treatment of certain adult and pediatric patients with chronic immune thrombocytopenia, certain adult patients with hepatitis C-associated thrombocytopenia, and certain adult and pediatric patients with severe aplastic anemia who have not received prior immunosuppressive therapy or had an insufficient response to immunosuppressive therapy. See promacta.com for full prescribing information. Promacta 12.5 mg for oral suspension was distributed nationwide through specialty pharmacies. Novartis is notifying its distributors and customers by letter and asking them to check for impacted product and to return unused product through directions provided in the recall letter. The affected product name, including the lot numbers and expiration dates, include: Impacted Promacta 12.5 mg for Oral Suspension Lot Numbers:

Product Description

NDC Number on Carton

NDC Number on Packet

Lot Number Expiration Date Distribution Dates

Promacta for Oral Suspension

0078-0972-61 0078-0972-19 8H57901589 09/2020 1/2/19 – 2/11/19


0078-0972-61 0078-0972-19 9H57900189 12/2020 2/11/19 – 4/17/19


0078-0972-61 0078-0972-19 9H57900289 12/2020 3/6/19 – 4/2/19

Consumers who have impacted product with these lot numbers and NDC numbers in their homes should contact 1-866-918-8772 (8:00 AM – 5:00 PM EST, Monday through Friday) for instructions on how to return recalled product. For all additional questions, please contact Novartis at 1-888-NOW NOVA (8:30 AM – 5:00 PM EST, Monday through Friday). Consumers should stop taking Promacta 12.5 mg oral suspension and consult with their healthcare provider. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Pharmacies that have impacted product with these lot numbers and NDC numbers should contact 1-866-918-8772 (8:00 AM – 5:00 PM EST, Monday through Friday) for instructions for return of recalled product. Healthcare professionals with questions can contact Novartis Medical Information at 1-844-ONC-INFO (1-844-622-4636) or at [email protected]. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration



STUDIES AND RECENT TOPICS

An eye drop a day could slow down nearsightedness in children April 20, 2019 What if something as simple as a daily eye drop could slow down nearsightedness in children? Nearsightedness is on the rise around the world. In the United States, nearsightedness increased in children aged 12-17 from 12% in the early 1970s to 30% by the early 2000s. In other areas of the world the amount of nearsightedness is even greater. For example, in some areas of China nearly 40% of schoolchildren are nearsighted. Source: idahopress.com Pharmacy Course Addresses Specific Challenges of Transgender Community April 23, 2019 A course aims to increase pharmacists’ knowledge about gender identity and the unique health care challenges of transgender patients. An unmet need led to introduction of a focus on transgender care into the existing curriculum. Source: pharmacytimes.com Combination Melasma Treatment with Fewer Active Components May Be Effective April 25, 2019 Approximately 62% of total decrease in melanin index was realized in the first 3 months. Patients with melasma using a new triple combination of traditional treatments containing active ingredients with lesser concentrations than proposed reported few side effects and significant improvement in their conditions. Source: dermatologyadvisor.com A Promising Peanut Allergy Treatment May Not Work So Well After All, Research Review Says April 25, 2019 Researchers came to a disappointing conclusion about recent studies on treating peanut allergies. They found that treating children by exposing them to small amounts of peanuts, which has shown success in several studies, is actually associated with an increased risk of allergic reactions, including anaphylaxis. Source: time.com Children and parents overestimate correct use of asthma inhalers by youngsters, study finds April 30, 2019 Research has shown that almost all children with asthma who are confident in their inhaler abilities are using their devices incorrectly. Many children with asthma think they are using their asthma inhaler medication correctly when they are not, making it difficult to keep the condition under control, a study has shown.



Source: pharmaceutical-journal.com ‘One-size-fits-all’ treatment targets harm frail older patients with diabetes April 30, 2019 HbA1c targets that ignore differences in the physiology of older patients put them at risk of severe hypoglycaemia, harm and death. Around 425 million people around the world are thought to have type 2 diabetes[1], and older people aged 80 years and over account for a growing proportion. In the UK, an estimated 13% of the population living with diabetes is aged over 80 years – equivalent to a fifth of people in this age group. Source: pharmaceutical-journal.com Chronic fatigue syndrome: New test in sight April 30, 2019 Scientists have developed a test for chronic fatigue syndrome that detects the reaction of the immune cells and blood plasma to stress. The findings may also help screen effective drugs for the condition. Source: medicalnewstoday.com Birth Control Pills May Help Prevent ACL Tears, Study Finds May 6, 2019 Anterior cruciate ligament (ACL) tears are common in sports like soccer and basketball, where jumping and pivoting can happen many times throughout a game. Although there are about 200,000 ACL injuries every year, female athletes are 2 to 8 times more likely to sustain an ACL injury than male athletes. Source: everydayhealth.com Synthetic CBD from Main Line biotech gets fast track status from FDA May 6, 2019 The U.S. Food and Drug Administration granted a Main Line biotech company “Fast Track” status for a synthetic cannabidiol drug that is intended to treat symptoms associated with the genetic condition Fragile X. Source: philly.com Dupixent's on a roll in eczema and asthma, but COPD's a ‘much tougher’ malady: Regeneron CEO May 7, 2019 Armed with new nods in asthma and adolescent eczema, Regeneron’s Dupixent keeps reeling in new biologics patients. But as phase 3 results in COPD loom, helmsman Len Schleifer warns that tapping into that disease could be “much tougher.” Source: fiercepharma.com



Diabetes Drugs Carry Risk of Gangrene of Genitals May 8, 2019 Popular diabetes drugs known as SGLT2 inhibitors appear to raise the chance of getting gangrene of the genital area, a rare but potentially fatal side effect, according to a new report. From March 2013, until Jan. 31, 2019, the FDA found 5 5 cases of this condition, known as Fournier gangrene, in people taking three different types of the SGLT2 inhibitors. The cases were reported to the FDA's Adverse Event Reporting System (FAERS) database. FAERS contains reports of harmful events from health care providers, drugmakers, patients, and others. Source: webmd.com Cholesterol-lowering drugs tied to reduced glaucoma risk May 8, 2019 High cholesterol is associated with an increased risk of developing glaucoma, but a new study suggests taking statins to lower cholesterol helps to reduce this risk. Glaucoma is a group of eye conditions that can damage the optic nerve, typically because pressure builds up inside the eye. The current study focused on the most common form, known as open-angle glaucoma, which starts with gradual loss of peripheral vision. Source: reuters.com Levodopa-Sparing Medications May Help Patients in Early Stages of Parkinson’s, Study Suggests May 13, 2019 Neurologists treating patients with early-stage Parkinson’s disease should prescribe more often therapies that spare patients from starting levodopa too soon in order to delay onset of side effects associated with long-term use of the medicine. Source: parkinsonsnewstoday.com Revisiting the Role of Histamines in Migraine May 15, 2019 Insufficient evidence exists to support the use of first-generation antihistamines (i.e., both H1 and H2) as preventive migraine medications, with sedation and weight gain recognized as unacceptable side effects. A literature search on the subject was conducted, with the investigators examining all eligible studies on histamine, antihistamines, and histamine receptors relative to migraine and the central nervous system. Source: neurologyadvisor.com



RECALLS

Product Type

Product Description

Classification Code Info Reason For Recall

Recalling Firm

Drugs FENTANYL Transdermal

System, 12 mcg/h, five (12 mcg/h)

systems per carton, Rx only, Distributed by:

Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.

Class I Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.

Product Mix-Up: Customer

complaint that their

carton labeled as Fentanyl

Transdermal Systems, 12

mcg/h contained five

patches labeled and

containing 50 mcg/h.

Alvogen, Inc

Drugs Dexmedetomidine 400 mcg in NS 100 mL bag, Made by:

Enterprise Pharmacy, 4400 Golf Acres Drive,

Bldg. J Suite E, Charlotte, NC,

28208.

Class II Lots: EA141908 Exp. 4/14/2019; EA171909 Exp. 4/17/2019; EA211906 Exp. 4/21/2019; EA251908 Exp. 4/25/2019; EB041905 Exp. 5/6/2019; EB071907 Exp. 5/8/2019; EB151909 Exp.

5/16/2019; EC041906 Exp. 6/2/2019; EC111907 Exp. 6/9/2019; EC181908 Exp.

6/16/2019; EC201907 Exp. 6/18/2019

Lack of sterility

assurance.

CMC Enterprise Pharmacy

Drugs Clindamycin 900 mg in NS 50 mL bag, Made by:



28208.

Class II Lots: EA211905 Exp. 4/21/2019; EB061906 Exp. 5/7/2019; EB131907 Exp.

5/14/2019; EB221907 Exp. 5/23/2019; EC251909 Exp.

6/23/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm

Drugs Diltiazem 250 mg in NS 250 mL bag,

Made by: Enterprise

Pharmacy, 4400 Golf Acres Drive,


28208.

Class II Lots: EA161906 Exp. 4/16/2019; EA181906 Exp. 4/18/2019; EA231907 Exp. 4/23/2019; EA241907 Exp. 4/24/2019; EB061907 Exp. 5/7/2019; EB201907 Exp.

5/21/2019; EC181909 Exp. 6/16/2019

Lack of sterility

assurance.


Drugs Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by:



28208.

Class II Lots: EA241908 Exp. 4/24/2019; EB011905 Exp. 5/2/2019; EB081909 Exp. 5/9/2019; EB151910 Exp.

5/16/2019; EB251909 Exp. 5/26/2019; EC061907 Exp. 6/4/2019; EC151906 Exp.

6/13/2019

Lack of sterility

assurance.


Drugs Magnesium Sulfate 1 GM in NS 50 mL bag, Made

by: Enterprise Pharmacy, 4400 Golf Acres Drive,


28208.

Class II Lots: EK051810 Exp. 5/4/2019; EK281808 Exp. 5/27/2019; EL101810 Exp. 6/8/2019; EL141807 Exp.

6/12/2019; EA081910 Exp. 7/7/2019; EA161908 Exp.

7/15/2019; EA301908 Exp. 7/29/2019; EB111907 Exp. 8/10/2019; EC041907 Exp.

8/31/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm




28208.

Class II Lots: EK021807, EK021807A Exp. 5/1/2019; EK261807 Exp. 5/25/2019; EK271808 Exp. 5/26/2019; EK301811 Exp. 5/29/2019; EL261811 Exp. 6/24/2019; EL281808 Exp. 6/26/2019; EA031908 Exp. 7/2/2019;

EA111908 Exp. 7/10/2019; EA181907 Exp. 7/17/2019; EA281908 Exp. 7/27/2019; EB071908 Exp. 8/6/2019;

EB201909 Exp. 8/19/2019; EC151907 Exp. 9/11/2019

Lack of sterility

assurance.





28208.

Class II Lots: EK131812 Exp. 5/12/2019; EL051809 Exp. 6/3/2019; EL111808 Exp. 6/9/2019; EL141808 Exp.

6/12/2019; EA031909 Exp. 7/2/2019; EA141909 Exp.

7/13/2019; EA311910 Exp. 7/30/2019; EB061909 Exp. 8/5/2019; EC121909 Exp. 9/8/2019; EC251910 Exp.

9/21/2019

Lack of sterility

assurance.





28208.

Class II Lots: EA111909 Exp. 7/10/2019; EB061910 Exp. 8/5/2019; EB131909 Exp.

8/12/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm

Drugs NICARdipine 25 mg in NS 250 mL EXCEL bag, Made



28208.

Class II Lots: EA161909 Exp. 4/16/2019; EA211907 Exp. 4/21/2019; EB041906 Exp. 5/5/2019; EB111908 Exp.

5/12/2019; EB181907 Exp. 5/19/2019; EB251910 Exp. 5/26/2019; EC111908 Exp. 6/9/2019; EC201909 Exp.

6/18/2019; EC261909 Exp. 6/24/2019; EC271919 Exp.

6/25/2019

Lack of sterility

assurance.


Drugs Norepinephrine 16 mg in NS 250

mL bag, Made by: Enterprise



28208.

Class II Lots: EA151909 Exp. 4/15/2019; EA251907 Exp. 4/25/2019; EA301909 Exp. 4/30/2019; EA311911 Exp. 5/1/2019; EB131910 Exp.

5/14/2019; EB201910 Exp. 5/21/2019; EB271909 Exp. 5/28/2019; EC081910 Exp. 6/6/2019; EC131908 Exp.

6/11/2019

Lack of sterility

assurance.


Drugs Oxytocin 30 units in NS 500 mL bag,

Made by: Enterprise



28208.

Class II Lots: EA241909 Exp. 4/24/2019; EA281909 Exp. 4/28/2019; EA301910 Exp. 4/30/2019; EB111909 Exp. 5/12/2019; EB141909 Exp. 5/15/2019; EB221908 Exp. 5/23/2019; EC061908 Exp. 6/4/2019; EC131909 Exp.

6/11/2019; EC261910 Exp. 6/24/2019

Lack of sterility

assurance.


Drugs Alteplase 1 mg/mL 1 mL in 10 mL

syringe, Made by: Enterprise



28208.

Class II Lots: ED021901 Exp. 5/17/2019; ED031921 Exp.

5/18/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm

Drugs Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1,

For Intradermal Use Only, Made by: Enterprise



28208.

Class II Lots: ED041901 Exp. 4/13/2019; ED051901 Exp. 4/14/2019; ED081901 Exp. 4/17/2019; ED01901 Exp.

4/18/2019; ED101901 Exp. 4/19/2019; ED111901 Exp.

4/20/2019

Lack of sterility

assurance.


Drugs Lidocaine 1% - Sodium Bicarb

8.4% 10:1, 10 mL syringe, For

Intradermal Use Only, Made by:



28208.


4/19/2019

Lack of sterility

assurance.


Drugs Lidocaine 1% - Sodium

Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise



28208.


04/14/2019; ED081902 Exp. 4/17/2019; ED091902 Exp. 4/18/2019; ED101903 Exp. 4/19/2019; ED111902

Exp. 4/20/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm

Drugs CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made



28208.

Class II Lots: a) ED051904 Exp. 4/14/2019; ED081903 Exp. 4/17/2019; ED091903 Exp. 4/18/2019; ED111903 Exp.

4/20/2019; b) EB271904 Exp. 4/13/2019; EB281904 Exp. 4/14/2019; EC011903 Exp. 4/15/2019; EC051904 Exp. 4/19/2019; EC071904 Exp. 4/21/2019; EC081905 Exp. 4/22/2019; EC121905 Exp. 4/26/2019; EC131903 Exp. 4/27/2019; EC141903 Exp. 4/28/2019; EC151903 Exp. 4/29/2019; EC181904 Exp. 5/2/2019; EC191905 Exp. 5/3/2019; EC211904 Exp. 5/5/2019; EC221905 Exp. 5/6/2019; EC251904 Exp. 5/9/2019; EC271904

Exp. 5/11/2019; EC281904 Exp. 5/12/2019; ED011904 Exp. 5/16/2019; ED021906 Exp. 5/17/2019; ED031904 Exp. 5/18/2019; ED041903 Exp. 5/19/2019; ED051905 Exp. 5/20/2019; ED081904 Exp. 5/23/2019; ED091904 Exp. 5/24/2019; ED101904 Exp. 5/25/2019; ED111904

Exp. 5/26/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm

Drugs CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made



28208.

Class II Lots: a) ED041904 Exp. 4/13/2019; ED051906 Exp. 4/14/2019; ED081905 Exp. 4/17/2019; ED091905 Exp. 4/18/2019; ED111905 Exp.

4/20/2019; b) EB271906 Exp. 4/13/2019; EB281906 Exp. 4/14/2019; EC051906 Exp. 4/19/2019; EC061905 Exp. 4/20/2019; EC071906 Exp. 4/21/2019; EC081907 Exp. 4/22/2019; EC111905 Exp. 4/25/2019; EC121907 Exp. 4/26/2019; EC131905 Exp. 4/27/2019; EC141905 Exp. 4/28/2019; EC151905 Exp. 4/29/2019; EC181906 Exp. 5/2/2019; EC191907 Exp. 5/3/2019; EC201905 Exp. 5/4/2019; EC211906 Exp. 5/5/2019; EC221907 Exp. 5/6/2019; EC251906 Exp. 5/9/2019; EC261906

Exp. 5/10/2019; EC271906 Exp. 5/11/2019; EC281906 Exp. 5/12/2019; EC011904 Exp. 5/16/2019; ED021908 Exp. 5/17/2019; ED031906

Exp. 05/18/2019; ED041905 Exp. 5/19/2019; ED051907 Exp. 5/20/2019; ED081906 Exp. 5/23/2019; ED091905 Exp. 5/24/2019; ED101906 Exp. 5/25/2019; ED111906 Exp. 5/26/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm

Drugs CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by:



28208.

Class II Lots: EB281907 Exp. 4/14/2019; EC011905 Exp. 4/15/2019; EC071907 Exp. 4/21/2019; EC081908 Exp. 4/22/2019; EC131906 Exp. 4/27/2019; EC141906 Exp. 4/28/2019; EC151919 Exp. 4/29/2019; EC181907 Exp. 5/2/2019; EC201906 Exp. 5/4/2019; EC211907 Exp. 5/5/2019; EC221908 Exp. 5/6/2019; EC251907 Exp. 5/9/2019; EC261907 Exp.

5/10/2019; EC271907 Exp. 5/11/2019; EC281907 Exp. 5/12/2019; EC011907 Exp. 5/16/2019; ED021909 Exp. 5/17/2019; ED031907 Exp. 5/18/2019; ED041906 Exp. 5/19/2019; ED051908 Exp. 5/20/2019; ED081907 Exp. 5/23/2019; ED091907 Exp.

5/24/2019

Lack of sterility

assurance.


Drugs CefTRIAXone 1 GM, 100 mg/mL,

10 mL syringe, Made by: Enterprise



28208.

Class II Lots: EB271907 Exp. 4/13/2019; ED041907 Exp.

5/19/2019

Lack of sterility

assurance.


Drugs Chlorothiazide 100 mg, 3.57 mL

syringe, Made by: Enterprise



28208.

Class II Lots: ED041908 Exp. 4/18/2019; ED051909 Exp. 4/19/2019; ED081908 Exp.

4/22/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm

Drugs Heparin Pork 30,000 Units in NS

1000 mL bag, Made by: Enterprise



28208.


4/19/2019

Lack of sterility

assurance.


Drugs Phenylephrine 0.8 mg/10 mL NS

(0.08 mg/mL), (80 mcg/mL) syringe,

Made by: Enterprise



28208.

Class II Lots: ED041911 Exp. 4/13/2019; ED051910 Exp. 4/14/2019; ED081910 Exp. 4/17/2019; ED091909 Exp. 4/18/2019; ED101910 Exp. 4/19/2019; ED111908 Exp.

4/20/2019

Lack of sterility

assurance.


Drugs Phenylephrine 20 mg NS 250 mL bag, Made by:



28208.

Class II Lots: ED051911 Exp. 4/14/2019; ED081911 Exp. 4/17/2019; ED091910 Exp. 4/18/2019; ED101911 Exp. 4/19/2019; ED111909 Exp.

4/20/2019

Lack of sterility

assurance.


Drugs Phenylephrine 40 mg in 0.9%

Sodium Chloride 250 mL bag, 160

mcg/mL, Made by: Enterprise



28208.


4/20/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm

Drugs Sodium Bicarbonate 150

mEq in D5W 1000 mL bags, Made by:



28208.

Class II Lots: ED041913 Exp. 4/13/2019; ED051913 Exp. 4/14/2019; ED081913 Exp.

4/17/2019; ED091913, ED091912 Exp. 4/18/2019; ED101914, ED101913 Exp. 4/19/2019; ED111911 Exp.

4/20/2019

Lack of sterility

assurance.


Drugs Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush

Syringe, Made by: Enterprise



28208.

Class II Lots: ED031915 Exp. 4/17/2019; ED041919 Exp. 4/18/2019; ED091914 Exp. 4/23/2019; ED111912 Exp.

4/25/2019

Lack of sterility

assurance.


Drugs Vancomycin 1000 mg in NS 250 mL

bag, Made by: Enterprise



28208.


4/20/2019

Lack of sterility

assurance.






28208.


4/20/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm





28208.


4/20/2019

Lack of sterility

assurance.


Drugs Vancomycin 1750 mg in 0.9%

Sodium Chloride 500 mL bag, Made



28208.

Class II Lots: ED041918 Exp. 4/13/2019; ED051917 Exp. 4/14/2019; ED081917 Exp. 4/17/2019j; ED091917 Exp.

4/18/2019; ED1019117 Exp. 4/19/2019; ED111915

Exp. 4/20/2019

Lack of sterility

assurance.


Drugs Vancomycin 2000 mg in 0.9%

Sodium Chloride 500 mL bag, Made



28208.


4/20/2019

Lack of sterility

assurance.




Product Type

Product Description


Recalling Firm

Drugs DelNido Cardioplegia

(Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL

bag) Mannitol 20%-16.3 mL,

Potassium Chloride 2

mEq/mL-13 mL, Sodium

Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL,

Magnesium Sulfate 500

mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by:



28208.


4/20/2019

Lack of sterility

assurance.


Drugs BPlex (METHYLCOBALA

MIN 1000 MCG/ML

PYRIDOXAL 5 PHOSPHATE 20MG/ML

DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ

COMPOUNDED. Customceutical Compounding

4611 E. Shea Blvd. Bldg 3 180,

Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 02082019@9, Exp 5/19/19

Lack of assurance of sterility for injectables

and solutions intended to be sterile.

Customceutical Compounding



Product Type

Product Description


Recalling Firm

Drugs BPlex (METHYLCOBALA

MIN 1000 MCG/ML

PYRIDOXAL 5 PHOSPHATE 20MG/ML

DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ

COMPOUNDED. Customceutical Compounding


Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 03122019@31, Exp 6/10/19




Drugs Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE

VIAL MDV Compounded.



Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 02132019@25, Exp 5/14/19




Drugs HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5

mL multidose vial compounded.



Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 03132019@23, Exp 5/12/19






Product Type

Product Description


Recalling Firm

Drugs Lipoplex (METHIONINE 25 MG/ML INOSITOL

50 MG/ML CHOLINE

CHLORIDE 50 MG/ML

HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL

50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE

VIAL INJ COMPOUNDED. Customceutical Compounding


Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 02212019@13, Exp 5/22/19




Drugs Test D (TESTOSTERONE

CYPIONATE 200MG/ML VITAMIN D3

5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding


Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 01232019@25, Exp 4/23/19






Product Type

Product Description


Recalling Firm

Drugs Test D (TESTOSTERONE

CYPIONATE 200MG/ML VITAMIN D3

5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding


Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 03132019@28, Exp 6/11/19




Drugs Test PROCYP (TESTOSTERONE

CYPIONATE 200MG/ML

TESTOSTERONE PROPIONATE

20MG/ML), 5 ML MULTIDOSE VIAL

INJ COMPOUNDED. Customceutical Compounding


Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 03112019@10, Exp 6/19/19






Product Type

Product Description


Recalling Firm

Drugs Trimix HIGH (Papaverine HCl

30 mg/mL Phentolamine

Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial

MDV Inj. Compounded.



Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 02182019@27, Exp 8/02/19




Drugs TriMix MEDIUM (Papaverine HCL

21 mg/mL Phentolamine Mesylate 0.7

mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV

Inj. Compounded. Customceutical Compounding


Phoenix, AZ 85028 Ph. 480 516 0272

Class II Lot #: 02182019@22, Exp 8/02/19






Product Type

Product Description


Recalling Firm

Drugs Revonto (dantrolene sodium for

injection), 20 mg/vial, For treatment of

malignant hyperthermia, For Intravenous Use

Only, Rx Only, Made in Italy, Dist.

by: US WorldMeds, LLC,

Louisville, KY 40241, NDC:

27505-003-67

Class II Lot: 17REV01, Exp. 12/2019 Presence of Precipitate:

Appearance is Out of

Specification for the

reconstituted solution

during 24-month

stability time point analysis.

US Worldmeds LLC

Drugs Losartan Potassium Tablets, USP, 25 mg, a) 90-

count (NDC: 13668-113-90), b)1000-count

(NDC: 13668-113-10) per bottle, Rx

only, Manufactured by:

Torrent Pharmaceuticals LTD, Indrad-382

721, Dist. Mehsana India

Class II Count, lots, expiry: [90-count bottle] Lot BDK1C003, exp

07/31/2019; [1000-count bottle] Lot BDK1C002, exp

07/31/2019; Lots 4DU1D004, 4DU1D005,

4DU1D006, exp 12/31/2019

CGMP Deviations:

FDA lab confirmed

presence of an impurity,

N-Methylnitroso

butyric acid (NMBA) in the

finished product above

the interim acceptable daily intake

level.

Torrent Pharma Inc.



Product Type

Product Description


Recalling Firm

Drugs Losartan Potassium Tablets, USP, 50 mg, a) 90-

count (NDC: 13668-409-90), b)1000-count





Class II Count, lots, expiry: [90-count bottle] Lots

4DU2D005, 4DU2D006, exp 12/31/2019; Lots

4DU2D026, 4DU2D027, 4DU2D029, exp 3/31/2020;

Lot 4DU2E007, exp 12/31/2020; [1000-count

bottle] Lot 4DU2D017, exp 2/29/2020, Lots

4DU2D025, 4DU2D028, exp 3/31/2020; Lots

4DU2D040, 4DU2D041, 4DU2D042, 4DU2D045, 4DU2D046, 4DU2D047,

4DU2D048, exp 8/31/2020; Lot BDK2E001, exp 12/31/2020; Lots

4DU2E042, 4DU2E044, exp 2/28/2021; Lots BDK2E012, BDK2E013, exp 8/31/2021

CGMP Deviations:

FDA lab confirmed


N-Methylnitroso




level.

Torrent Pharma Inc.

Drugs Losartan Potassium Tablets,

USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count





Class II Count, lots, expiry: [90-count bottle] Lot 4DU3E016, exp

01/31/2021; [1000-count bottle] Lot 4DU3C012, exp

7/31/2019; Lots 4DU3C015, 4DU3C016, 4DU3C017, exp 8/31/2019; Lot 4DU3C031,

exp 9/30/2019; Lots 4DU3D007, 4DU3D008,

exp 1/31/2020; Lot 4DU3E017, exp 1/31/2021;

Lot 4DU3E019, exp 2/28/2021

CGMP Deviations:

FDA lab confirmed


N-Methylnitroso




level.

Torrent Pharma Inc.



Product Type

Product Description


Recalling Firm

Drugs Losartan Potassium and

Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC:

13668-116-30), b) 90-count (NDC:

13668-116-90), c) 1000-count (NDC:

13668-116-10), per bottle, Rx




Class II Count, lots, expiry: [30-count bottle] Lot BP02C051, exp

10/31/2019; Lot BP02D005, exp 12/31/2019; Lot

BEF7D047, exp 11/30/2020; [90-count

bottle] Lot BP02C050, exp 10/31/2019; Lots

BP02D006, BP02D007, exp 12/31/2019; Lot BP02D012,

exp 1/31/2020; Lot BEF7D003, exp 3/31/2020; Lots BEF7D026, BEF7D027, BEF7D028, exp 8/31/2020; Lots BEF7D045, BEF7D046,

exp 11/30/2020; Lot BEF7E005, exp 1/31/2021; [1000-count bottle] Lots

BP02C051, BP02C052, exp 10/31/2019; Lot BEF7D005,

exp 3/31/2020; Lots BEF7D029, BEF7D030, exp 8/31/2020; Lot BEF7D048,

exp 11/30/2020; Lots BEF7E001, BEF7E002,

BEF7E003, BEF7E004, exp 12/31/2020

CGMP Deviations:

FDA lab confirmed


N-Methylnitroso




level.

Torrent Pharma Inc.



Product Type

Product Description


Recalling Firm


Hydrochlorothiazide Tablets, USP,

100mg/12.5mg, a) 90-count (NDC:

13668-117-90), b) 1000-count (NDC:

13668-117-10), per bottle, Rx




Class II Count, lots, expiry: [90-count bottle] Lot

BX35D024, exp 1/31/2020; BEF8D060, BEF8D061, BEF8D062, BEF8D063,

BEF8D064, exp 11/30/2020; [1000-count bottle] Lot BEF8D059, exp

11/30/2020; Lots BEF8E004, BEF8E005, exp

1/31/2021

CGMP Deviations:

FDA lab confirmed


N-Methylnitroso




level.

Torrent Pharma Inc.


Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC:

13668-118-30) b) 90-count (NDC:

13668-118-90), c) 1000-count (NDC:

13668-118-10), per bottle, Rx




Class II Count, lots, expiry: [30-count bottle] Lot

BEF6D054, exp 8/31/2020; [90-count bottle] Lot

BP04C092, exp 10/31/2019; Lots

BP04D012, BP04D013, exp 12/31/2019; Lots

BEF6D012, BEF6D013, exp 3/31/2020; Lots BEF6D060, BEF6D061, BEF6D063, exp 9/30/2020; Lots BEF6D076,

BEF6D077, BEF6D078, BEF6D079, exp

10/31/2020; Lots BEF6D100, BEF6D101,

BEF6D102, exp 11/30/2020; Lots

BEF6E001, BEF6E002, BEF6E003, BEF6E004, BEF6E008, BEF6E009, BEF6E010, BEF6E011,

BEF6E012, exp 12/31/2020

CGMP Deviations:

FDA lab confirmed


N-Methylnitroso




level.

Torrent Pharma Inc.



Product Type

Product Description


Recalling Firm

Drugs BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe

Intravitreal Injection. This

biologic product was repackaged

by AmEx Pharmacy 1515

Elizabeth St. Suite J Melbourne, FL

32901 Lot:190212AB

BUD:5/13/2019, Repackaged on

2/12/2019

Class II Lot: 190212AB BUD: 5/13/2019

Defective Delivery System:

difficult to express

Pacifico National, Inc.

dba AmEx Pharmacy

Drugs Losartan Potassium Tablets

USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC

50268-517-15 Manufactured for:

AvKARE Inc. Pulaski, TN 38478

Class II Lot: 20121 Exp. 6/30/2019 CGMP Deviations:

FDA lab confirmed


N-Methylnitroso



the interim acceptable daily intake level of 0.96

parts per million.

AVKARE Inc.



Product Type

Product Description


Recalling Firm

Drugs Losartan Potassium Tablets

USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC

50268-516-15 Manufactured for:

AvKARE Inc. Pulaski, TN 38478

Class II Lot: 19554 Exp. 4/30/2019 CGMP Deviations:

FDA lab confirmed


N-Methylnitroso




parts per million.

AVKARE Inc.

Drugs Losartan Potassium Tablets,

USP, 50 mg, 30 tablet bottles, Rx Only, Distributed

by: The Kroger Co, Cincinnati, OH

45202, Manufactured for:

Torrent Pharma Inc., 150 Allen

Road, Suite 102, Basking Ridge, NJ 07920, Packaged

by: Legacy Pharmaceutical Packaging LLC, Earth City, MO

63045 NDC 68645-494-54

Class II Lot 181598; 02/2021 CGMP Deviations:

Detection of trace amounts

of N-Methylnitroso

butyric acid (NMBA) impurity

found in the Active

Pharmaceutical Ingredient

(API)

Legacy Pharmaceutical Packaging LLC



Product Type

Product Description


Recalling Firm

Drugs HYDROmorphone 20 mg/100 mL

Injectable Solution,

Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded

Drug, Avella of Houston 9265

Kirby Dr., Houston, TX

77054 (877) 794-0404, NDC: 42852-

221-10

Class II Lot: 01/14/19 0215 22110P Exp. 04/29/2019

Sub-potency Advanced Pharma Inc.

Drugs Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count

bottle, Manufactured by

Torrent Pharmaceuticals,

Distributed by RemedyRepack, Inc. Indiana, PA,

15701-3570, NDC 70518-1560-00.

Class II Lot #: B0517068-101618, Exp. Date: 10/2019

CGMP Deviations:

FDA lab confirmed


N-Methylnitroso




parts per million.

RemedyRepack Inc.



Product Type

Product Description


Recalling Firm

Drugs Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx

Only Manufactured by: Cadila Healthcare

Ltd., India Distributed by:

Zydus Pharmaceuticals

(USA) Inc. Pennington, NJ

USA 08534 NDC 68382-791-01

Class II Z804517, Nov 30, 2020 Labeling; Label Mix-up;

report received of one bottle labeled as Acyclovir

Tablets USP 400 mg actually

contained Carvedilol

Tablets 6.25 mg

Zydus Pharmaceutical

s USA Inc

Drugs Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx

Only Manufactured by: Cadila Healthcare

Ltd., India Distributed by:


(USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

Class II Z804517, exp Nov 30, 2020 Labeling; Label Mix-up;

report received of one bottle labeled as Acyclovir

Tablets USP 400 mg actually

contained Carvedilol

Tablets 6.25 mg


s USA Inc



Product Type

Product Description


Recalling Firm

Drugs Ketorolac Tromethamine

Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL

Vials, Rx only, Mfd. for Sagent

Pharmaceuticals, Schaumburg, IL

60195, NDC: 25021-701-02

Class II Lot #: M813513, Exp. Feb 2020

Lack of Sterility

Assurance: Microbial

growth detected during a routine

simulation of the

manufacturing process,

which represents the

potential introduction

of microorganisms into the products.

Sagent Pharmaceutical

s Inc

Drugs Losartan Potassium Tab.

USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count

bottle (NDC 68788-0048-09),

Rx only, Preferred Pharmaceuticals,

Inc., Anaheim, CA, Mfg: Torrent Pharma Inc.,

Basking Ridge, NJ

Class II a) 30 tablets: lot A1818G batch 01181807 exp

3/2020; b) 90 tablets: lot L0517L batch 12051712

exp 3/2020

CGMP Deviations:

FDA lab confirmed


N-Methylnitroso



the interim acceptable daily intake level at the

manufacturer

Preferred Pharmaceutical

s, Inc



Product Type

Product Description


Recalling Firm

Biologics Bexsero, PFS 0.5 ml (1/BX), Catalog No. 58160097606

Class III 1047589 Multiple vaccines, lacking

assurance of proper storage

temperatures, were

distributed.

MCKESSON MEDICAL

Biologics MENVEO VACCINE, SDV 10-5MG/0.5, Catalog No. 58160095509



temperatures, were

distributed.

MCKESSON MEDICAL

Biologics BOOSTRIX, TDAP SYR 2.5-

8.5MG/0.5ML 0.5ML (10/PK)

SMKLP, Catalog No. 58160084252



temperatures, were

distributed.

MCKESSON MEDICAL

Biologics TDVAX, SDV 0.5ML (10/PK),

Catalog No. 13533013101



temperatures, were

distributed.

MCKESSON MEDICAL



Product Type

Product Description


Recalling Firm

Biologics PPD APLISOL, VL 5TU/0.1ML

1ML(10TEST/VL), Catalog No.

42023010401



temperatures, were

distributed.

MCKESSON MEDICAL

Biologics PPD TUBERSOL TUBERCULIN, VL 5TU/0.1ML 1ML 10TEST, Catalog

No. 752-21



temperatures, were

distributed.

MCKESSON MEDICAL

Biologics ADACEL TDAP VACCINE, SYR

ADLT2MG-2.5MG-5MG/0.5ML

(5/BX), Catalog No. 49281040020



temperatures, were

distributed.

MCKESSON MEDICAL

Biologics AFLURIA 2018, QUAD SYR 0.5ML

(10DOSE/BX), Catalog No.

33332031801



temperatures, were

distributed.

MCKESSON MEDICAL



Product Type

Product Description


Recalling Firm

Drugs Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg

tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by

Roerig, Division of Pfizer Inc, NY

10017.

Class III Lot #s: a) W38322, Exp 10/2020, W98482, Exp

03/2021; b) W64062, Exp 01/2021, X27517, Exp 03/2021, AJ3674, Exp

11/2021.

Labeling: Label Error on

Declared Strength: an

artwork error on the

secondary packaging of Relpax 40 mg

Tablets, indicates that

each tablet contains

eletriptan hydrobromide equivalent to

20mg eletriptan, instead of

40mg, on one side of the

carton.

Pfizer Inc.

Drugs Morphine Sulfate Extended-Release

Tablets, 15 mg, 100-count bottles,

Rx Only, Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Manufactured for: Lupin

Pharmaceuticals, Inc. Baltimore, MD

21202, NDC 43386-540-01

Class III Lot#: S700220, Exp. Apr 30 2019; S700604, Exp. July 31

2019; S800326, Exp. Mar 31 2020

Failed Impurities/De

gradation Specifications

LUPIN SOMERSET



Product Type

Product Description


Recalling Firm





Somerset, NJ 08873



21202 NDC 43386-541-01

Class III Lot#: S700221, Exp. Apr 30 2019; S700605, Exp. July 31 2019; S800232, Exp. Feb 29

2020.



LUPIN SOMERSET





Somerset, NJ 08873



21202 NDC 43386-542-01

Class III Lot#: S700222 Exp. Apr 30 2019 ; S800233 Exp, Feb 29

2020



LUPIN SOMERSET



Product Type

Product Description


Recalling Firm

Drugs Morphine Sulfate Extended-Release Tablets, 100 mg,

100-count bottles, Rx Only,

Manufactured by: Novel

Laboratories, Inc. Somerset, NJ

08873 Manufactured for:

Lupin Pharmaceuticals,

Inc. Baltimore, MD 21202 NDC

43386-543-01

Class III Lot#: S700223 Exp. Apr 30 2019; S800467, Exp. Mar

31 2020.



LUPIN SOMERSET

Drugs Morphine Sulfate Extended-Release Tablets, 200 mg

Rx Only 100 Tablets

Manufactured by: Novel

Laboratories, Inc. Somerset, NJ

08873 Manufactured for:

Lupin Pharmaceuticals,

Inc. Baltimore, MD 21202 NDC

43386-544-01

Class III Lot#: S700224 Exp. Apr 30 2019; S800469 Exp. Mar

31 2020



LUPIN SOMERSET



Product Type

Product Description


Recalling Firm

Drugs Fentanyl Citrate Injection, USP,

100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL

each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-

25

Class III Lot #: 011198, Exp 01/22 Failed impurities/de

gradation specification:

Out of Specification

result for total impurity at 4.0% (Limit:

NMT 3.0%) at 12 months

stability testing.

Akorn Inc

Drugs Carvedilol Tablets, USP, 3.125 mg,

500-count bottle, Rx Only,

Manufactured by: Cadila Healthcare

Ltd., India; Distributed by:


(USA) Inc., Pennington, NJ

08534; NDC 68382-092-05

Class III Lot #: Z803518, Exp 08/2020

Presence of Foreign

Tablets/Capsules: Customer complaint for a small, solid, light yellow substance,

identified as a fragmented

tablet of another drug

product, found mixed

with tablets in a bottle of Carvedilol

tablets 3.125mg.


s USA Inc



Product Type

Product Description


Recalling Firm

Drugs Dermoplast Anesthetic PAIN & ITCH (benzocaine

and menthol) SPRAY canisters, 20%, 0.5%, Net

WT 2.75 oz (78g); Distributed by

Moberg Pharma North America

LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6

Class III Lot #: 14049A, Exp 12/21 Labeling: Not Elsewhere Classified: canisters

incorrectly state the net weight is 2.75

oz. rather than the

correct net weight of 2.0

oz.

Advantice Health

Drugs Dermoplast Anesthetic PAIN & ITCH (benzocaine

and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz.

cans only; Distributed by

Moberg Pharma North America

LLC, Cedar Knolls, NJ 07927;

Product Code 80-6802; Case UPC 1 03 16864 68002 7.

Class III Lot #: 14049A, Exp 12/21 Labeling: Not Elsewhere

Classified: Full cases may

contain canisters that

incorrectly state the net weight is 2.75

oz. rather than the

correct net weight of 2.0

oz.

Advantice Health

*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm



CURRENT DRUG SHORTAGES

Temazepam Capsules April 25, 2019 Reasons for the Shortage

Ascend did not provide a reason for the shortage. Major has temazepam on shortage due to manufacturing delays. Mylan has temazepam on shortage due to manufacturing delays. Sun Pharma has temazepam available. Teva did not provide a reason for the shortage. Mallinckrodt has Restoril capsules available.

Estimated Resupply Dates

Ascend has temazepam 15 mg capsules in 100 count on allocation. The 7.5 mg capsules in 100 count and 30 mg capsules in 500 count are on back order and the company cannot estimate a release date.

Major has temazepam 7.5 mg capsules in 100 count bottles on back order and the company cannot estimate a release date.

Mylan has temazepam 15 mg capsules in 100 and 500 count, 22.5 mg capsules in 30 count, and 30 mg capsules in 100 and 500 count on back order and the company estimates a release date of August 2019.

Mylan Institutional has temazepam 30 mg capsules in 100 count unit-dose packs on back order and the company estimates a release date of early-September 2019.

Teva has temazepam 15 mg capsules in 100 count and 500 count and 30 mg capsules in 100 count and 500 count on back order and the company estimates a release date of early-May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=503 Flurazepam Capsules April 25, 2019 Reasons for the Shortage

Mylan did not provide a reason for the shortage. They are the sole suppliers of flurazepam.


Mylan has flurazepam 15 mg and 30 mg capsules on back order and the company estimates a release date of early- to mid-December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=557 Cyclosporine Capsules April 25, 2019 Reasons for the Shortage

Apotex has cyclosporine capsules available. Sandoz has discontinued cyclosporine (modified) capsules.




Teva has cyclosporine 25 mg and 50 mg modified capsules on back order and the company estimates a release date of late-May 2019 for the 25 capsules and late-June 2019 for the 50 mg capsules.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=476 Yellow Fever Vaccine April 26, 2019 Reasons for the Shortage

Sanofi Pasteur states the shortage of YF-Vax is due to production delays. [1] There are no other suppliers of yellow fever vaccine. Additional information on the yellow fever shortage is available at

http://wwwnc.cdc.gov/travel/news-announcements/yellow-fever-vaccine-shortage-2015. Estimated Resupply Dates

Sanofi Pasteur has YF-Vax multi-dose vials and single dose vials on back order and the company does not expect product to return to market in 2019.

FDA accepted an investigational new drug application in October 2016. This is for the importation of another yellow fever vaccine from France. The trade name of the imported product is Stamaril. The product information can be found at https://s3.amazonaws.com/filecache.drivetheweb.com/mr5str_sanofipasteur/202281/969800.pdf. The initial rollout began in April 2017. More information can be found at https://www.cdc.gov/mmwr/volumes/66/wr/mm6617e2.htm?s_cid=mm6617e2_w or at https://www.vaccineshoppe.com/index.cfm?fa=anon.content&n=YellowFever&title=.

Stamaril is on allocation due to supply demand. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=197

Sodium Acetate Injection April 28, 2019 Reasons for the Shortage

American Regent is not currently marketing sodium acetate injection. Fresenius Kabi has sodium acetate injection available. Pfizer has sodium acetate injection available.


Pfizer has sodium acetate 2 mEq/mL 100 mL vials available in limited supply. The 50 mL vials are on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=317 Potassium Phosphate Injection April 28, 2019 Reasons for the Shortage

American Regent has not had potassium phosphate injection available since 2012. It is unclear if and when product will return to market.

Fresenius Kabi had potassium phosphate injection on shortage due to increased demand. Pfizer had potassium phosphate injection on shortage due to manufacturing delays.


Pfizer has potassium phosphate 3 mmol/mL 15 mL vials available in limited supply.



https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=305 Mitoxantrone Hydrochloride Injection April 28, 2019 Reasons for the Shortage

Fresenius Kabi has mitoxantrone available. Pfizer had mitoxantrone injection on shortage due to manufacturing delays. Teva has mitoxantrone injection available except for the 10 mL vials which are temporarily

discontinued. Estimated Resupply Dates

Pfizer has mitoxantrone 2 mg/mL 12.5 mL vials on back order and the company estimates a release date of May 2019. There are limited supplies of short-dated 12.5 mL vials with an expiration date of August 2019.

Teva has temporarily discontinued mitoxantrone 10 mL vials and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=189 Magnesium Sulfate Injection April 28, 2019 Reasons for the Shortage

American Regent is not currently marketing magnesium sulfate which has been unavailable since late 2012.

Fresenius Kabi had magnesium sulfate injection on shortage due to increased demand for the product.

Pfizer has magnesium sulfate injection on shortage due to manufacturing delays. X-Gen discontinued magnesium sulfate in April 2018. Exela launched magnesium sulfate vials in May 2018. WG Critical Care had magnesium sulfate injection on shortage due to increased demand for the

product. Estimated Resupply Dates

Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of December 2019. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of June 2019. The 80 mg/mL 50 mL bags are on back order and the company estimates a release date of May 2019. The 40 mg/mL 500 mL bags are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Furosemide Injection April 28, 2019 Reasons for the Shortage

American Regent is not actively marketing furosemide injection. Amneal did not provide a reason for the shortage. Baxter (formerly Claris) did not provide a reason for the shortage. Fresenius Kabi did not provide a reason for the shortage. Heritage has furosemide injection available.



Pfizer had furosemide injection on shortage due to manufacturing delays and increased demand.


Amneal has furosemide 10 mg/mL 2 mL and 10 mL vials on back order and the company cannot estimate a release date. There are short-dated 4 mL vials available

Fresenius Kabi has furosemide 10 mg/mL 2 mL vials on back order and the company estimates a release date of late-May 2019.

Pfizer has furosemide 10 mg/mL 4 mL syringes and 2 mL vials on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=323 50% Dextrose Injection April 28, 2019 Reasons for the Shortage

Amphastar has 50% dextrose injection on allocation due to increased demand. Pfizer has 50% dextrose injection on shortage due to manufacturing delays.


Pfizer has 50% dextrose 50 mL LifeShield syringes on back order and the company estimates a release date of May 2019. The 50% dextrose 50 mL Ansyr syringes are on back order and the company estimates a release date of May 2019. The 50% dextrose 50 mL vials are on back order and the company estimates a release date of May 2019.

Amphastar has 50% dextrose 50 mL Luer-Jet syringes on allocation with regular releases. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=306 25% Dextrose Injection April 28, 2019 Reasons for the Shortage

Pfizer has 25% dextrose on shortage due to manufacturing delays.

Estimated Resupply Dates Pfizer has 25% dextrose 10 mL Ansyr syringes available with intermittent stock outs.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=483 14.6% Sodium Chloride Concentrated Solution for Injection April 28, 2019 Reasons for the Shortage

Pfizer has 14.6% sodium chloride concentrated solution for injection on shortage due to manufacturing delays.


Pfizer has 14.6% sodium chloride concentrated solution for injection 20 mL vials on back order and the company estimates a release date of March 2020. The 40 mL vials are available in limited supply.

Fresenius Kabi has 14.6% sodium chloride concentrated solution for injection 40 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=416



0.9% Sodium Chloride 10ml, 20ml, and 50ml Preservative Free Vials and Syringes April 28, 2019 Reasons for the Shortage

Fresenius Kabi has recalled multiple lots of 0.9% sodium chloride 10 mL and 20 mL vials due to labels incorrectly stating the stoppers are latex-free. The letter and the lot numbers affected can be found at https://www.fresenius-kabi.com/us/news/fresenius-kabi-issues-voluntary-nationwide-recall-of-sodium.

Pfizer has 0.9% sodium chloride preservative-free vials on shortage due to manufacturing delays.


Pfizer has 0.9% sodium chloride preservative free 20 mL and 50 mL vials on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=332 Epinephrine Injection April 29, 2019 Reasons for the Shortage

Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.

Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017. BPI has epinephrine 1 mg/mL 2 mL ampules available. Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.


Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation. Pfizer has epinephrine 0.1 mg/mL 10 mL syringes on back order and the company estimates a

release date of May 2019. Snap Medical Industries has the Epinephrine Snap-V Kit available. Each kit contains an

epinephrine 1 mg/mL 1 mL vial, (3) 1 mL luer lock syringes, and (3) 23-gauge 1-inch needles. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313 Cefoxitin Sodium Injection April 29, 2019 Reasons for the Shortage

Apotex has temporarily discontinued cefoxitin vials. BBraun has cefoxitin on allocation due to increased demand. Fresenius Kabi did not provide a reason for the shortage. Hikma did not provide a reason for the shortage. Hikma is not currently marketing cefoxitin. Sagent has cefoxitin on shortage due to increased demand and manufacturing delay. WG Critical Care did not provide a reason for the shortage.


Apotex has temporarily discontinued cefoxitin 1 gram, 2 gram, and 10 gram vials and the company cannot estimate when product will be available again.



BBraun has cefoxitin 1 gram and 2 gram DUPLEX bags on back order and the company cannot estimate a next release date.

Fresenius Kabi has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a release date of mid-May 2019 for the 1 gram vials and late-May 2019 for the 2 gram vials.

Sagent has cefoxitin 1 gram, 2 gram, and 10 gram vials on back order and the company estimates a release date of May 2019 for the 1 gram and 2 gram vials and July 2019 for the 10 gram vials.

WG Critical Care has cefoxitin 1 gram, 2 gram, and 10 gram vials on back order and the company estimates a release date of late-May 2019 for the 1 gram and 10 gram vials. The company cannot estimate a release date for the 2 gram vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=271 Valproate Sodium Injection April 30, 2019 Reasons for the Shortage

Abbvie did not provide a reason for the shortage. Hikma did not provide a reason for the shortage. Fresenius Kabi did not provide a reason for the shortage.


Abbvie has Depacon vials available with an expiration date of November 2019. Fresenius Kabi has valproate sodium injection 100 mg/mL 5 mL vials on back order and the

company estimates a release date of late-May 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=551 Thrombin Tropical Solution (Bovine) April 30, 2019 Reasons for the Shortage

Pfizer has Thrombin-JMI on shortage due to manufacturing delays. Recombinant thrombin is not affected by this shortage.


Pfizer has Thrombin-JMI 20,000 unit syringe spray kits, 5,000 unit epistaxis kits, 5,000 unit vials, and 20,000 unit vials available in limited supply. The 20,000 unit pump spray kits are on back order and the company estimates a release date of July 2019. The 5,000 unit syringe spray kits are on back order and the company estimates a release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=479 Sufentanil Injection April 30, 2019 Reasons for the Shortage

Akorn had Sufenta injection on shortage due to increased demand for the product. Hikma stopped marketing sufentanil injection in October 2018. Pfizer has sufentanil injection on shortage due to manufacturing delays.




Pfizer has sufentanil 0.5 mg/mL 2 mL vials on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=376 Secobarbital Capsules April 30, 2019 Reasons for the Shortage

Bausch Health is the sole supplier of secobarbital capsules. The company states that Seconal capsules are on back order due to a short-term stock out.


Bausch Health has Seconal (secobarbital) 100 mg capsules on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=517 Nelarabine Injection April 30, 2019 Reasons for the Shortage

Novartis did not provide a reason for the shortage. Estimated Resupply Dates

Novartis has Arranon 5 mg/mL 50 mL vials on a limited allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=458 Morphine Sulfate Immediate-Release Tablets April 30, 2019 Reasons for the Shortage

Hikma did not provide a reason for the shortage.

Estimated Resupply Dates Hikma has all morphine immediate-release tablets on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=504 Ketamine Injection April 30, 2019 Reasons for the Shortage

Hikma did not provide a reason for the shortage. Mylan Institutional did not provide a reason for the shortage. Par has Ketalar on shortage due to increased demand. Pfizer has ketamine on shortage due to manufacturing delays.


Hikma has ketamine 50 mg/mL 10 mL and 100 mg/mL 5 mL vials on allocation. Mylan Institutional has ketamine 50 mg/mL 10 mL vials and 100 mg/mL 10 mL vials on back

order and the company estimates a release date of mid- to late-May 2019. Pfizer has ketamine 50 mg/mL 10 mL vials on back order and the company estimates a release

date of January 2020. The 100 mg/mL 5 mL vials are on back order and the company estimates a release date of April 2020.



Par has Ketalar 10 mg/mL 20 mL vials, 50 mg/mL 10 mL vials, and 100 mg/mL 5 mL vials on intermittent back order with monthly releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=391 Fluphenazine Tablets April 30, 2019 Reasons for the Shortage

Lannett has fluphenazine tablets available. Mylan did not provide a reason for the shortage. The company discontinued fluphenazine

tablets in bottles in mid-2019. Estimated Resupply Dates

Mylan has all fluphenazine tablet unit dose presentations on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=478 Diphenhydramine Injection April 30, 2019 Reasons for the Shortage

Fresenius Kabi had diphenhydramine injection on shortage due to increased demand. Hikma did not provide a reason for the shortage. Mylan did not provide a reason for the shortage. Pfizer has diphenhydramine injection on shortage due to manufacturing delays.


Mylan Institutional has diphenhydramine 50 mg/mL 10 mL vials on back order and the company estimates a release date of mid-May 2019.

Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=456 Albuterol Sulfate Extended-Release Tablets April 30, 2019 Reasons for the Shortage

Mylan did not provide a reason for the shortage. They are the sole suppliers of albuterol sulfate extended-release tablets.

Estimated Resupply Dates Mylan has albuterol sulfate 4 mg and 8 mg extended-release tablets on back order and the

company estimates a release date of early- to mid-July 2019 for the 4 mg tablets and mid- to late-June 2019 for the 8 mg tablets.




Valsartan Tablets May 1, 2019 Reasons for the Shortage

Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probably human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

Camber, Major, Solco, and Teva valsartan tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

Major, Solco, and Teva discontinued valsartan tablets in July 2018. Alembic, Aurobindo, Cadista, Mylan, Macleods, and Novartis are not affected by this recall. Aurobindo refused to provide updated availability information. Lupin is not actively marketing valsartan tablets. Repackagers may have some presentations affected depending on the source supplier.


Alembic has all 500 count presentations on back order and the company cannot estimate a release date.

Cadista has valsartan tablets on back order and the company estimates a release date of early- to mid-May 2019.

Camber has valsartan tablets on back order and the company cannot estimate a release date. Mylan has valsartan tablets on back order and the company estimates a release date in late-

April to early-May 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=444 Valsartan and Hydrochlorothiazide Tablets May 1, 2019 Reasons for the Shortage

Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probable human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

Solco and Teva valsartan/hydrochlorothiazide tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

Solco and Teva discontinued valsartan/hydrochlorothiazide tablets in July 2018. Alembic, Aurobindo, Lupin, Mylan, Macleods, and Novartis are not affected by this recall. Aurobindo refused to provide updated availability information. Lupin did not provide a reason for the shortage. Mylan is discontinuing valsartan/hydrochlorothiazide 160 mg/12.5 mg in 500 count bottles. Repackagers may have some presentations affected depending on the source supplier.


Mylan has all valsartan/hydrochlorothiazide presentations on back order and the company cannot estimate a release date.



Lupin has all valsartan/hydrochlorothiazide presentations on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=445 Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution May 1, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage. Altaire is not currently marketing polyvinyl alcohol 1.4% ophthalmic solution. Major did not provide a reason for the Liquitears shortage. Ocusoft has polyvinyl alcohol 1.4% ophthalmic solution available. Rugby has polyvinyl alcohol 1.4% ophthalmic solution available.


Akorn has Artificial Tears Solution ophthalmic drops on allocation. Major has Liquitears ophthalmic drops on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=451 Mineral Oil and Petrolatum Ophthalmic Ointment May 1, 2019 Reasons for the Shortage

Allergan states the shortage is due to production delays. Bausch Health has Soothe Night Time ointment available. Major did not provide a reason for the shortage. Alcon states the shortage is due to manufacturing issues. Perrigo discontinued Puralube ointment products in early-2019. Rugby discontinued Artificial Tears 3.5 gram tubes in April 2019.


Alcon has Systane Nighttime ointment and Genteal PM ointment on back order and the company estimates a release date in mid-May 2019.

Allergan has Refresh PM, Lacri-Lube SOP ointment 3.5 gram, and Lacri-Lube SOP ointment 7 gram tubes on back order and the company estimates a release date in late-summer 2019.

Major has Lubrifresh PM 3.5 gram tubes on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435 Metoclopramide Injection May 1, 2019 Reasons for the Shortage

Pfizer has metoclopramide injection on shortage due to manufacturing delays. Teva had metoclopramide injection on shortage due to increased demand. Fresenius Kabi had metoclopramide injection on shortage due to increased demand.


Pfizer has metoclopramide 5 mg/mL 2 mL vials on back order and the company estimates a release date of May 2019.




Methylene Blue May 1, 2019 Reasons for the Shortage

Akorn has methylene blue on shortage due to manufacturing delays. They are not currently marketing the 1 mL vials.


Akorn has methylene blue 10 mg/mL 10 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=47 Labetalol Injection May 1, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage. Alvogen did not provide a reason for the shortage. Pfizer has labetalol injection on shortage due to manufacturing delays. Hikma has labetalol injection on shortage due to increase demand.


Akorn has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot estimate a release date.

Alvogen has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and the company estimates a release date of mid-May 2019.

Hikma has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and the company estimates a release date of May 2019.

Pfizer has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a release date of December 2019 for the 20 mL vials and January 2021 for the 40 mL vials. The 5 mg/mL 4 mL Carpuject syringes are on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286 Fentanyl Citrate Injection May 1, 2019 Reasons for the Shortage

Akorn has fentanyl injection on shortage due to increased demand. They are not currently marketing 25 count fentanyl ampules.

Hikma has fentanyl injection on shortage due to supply and demand issues. They are not currently marketing fentanyl ampules, just vials.

Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules were discontinued in September 2017.


Pfizer has fentanyl 50 mcg/mL 2 mL vials on back order and the company estimates a release date of May 2019. The 2 mL ampules, 20 mL vials, and 50 mL vials are available in limited supply



The 2 mL Carpuject syringes are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315 Degarelix Acetate Injection May 1, 2019 Reasons for the Shortage

Ferring did not provide a reason for the shortage. Estimated Resupply Dates

Ferring has Firmagon 80 mg vials on back order with an estimated release date of mid-May 2019. Emergency stock is available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=560 BCG Live Intravesical May 1, 2019 Reasons for the Shortage

Because of increased global demand, and as the only source of BCG Live (Intravesical) in the United States and many other countries, Merck anticipates supply constraints for Tice BCG in 2019. To minimize disruption to patient care and address the current imbalance between supply and increased global demand, Tice BCG will be under allocation when demand exceeds production plans and available inventory.


BCG live intravesical contains live attenuated mycobacteria and is labeled for the treatment and prophylaxis of carcinoma in situ of the urinary bladder. BCG live intravesical is also labeled for prophylaxis of primary or recurring stage Ta or T1 papillary tumors following transurethral resection.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=519 Rosuvastatin Calcium Tablets May 2, 2019 Reasons for the Shortage

Accord, Biocon, Glenmark, Mylan, Sandoz, and Rising did not provide a reason for the shortage. Apotex has discontinued production of all rosuvastatin presentations. Aurobindo refuses to provide updated availability information. Mylan has discontinued all rosuvastatin presentations. Sun Pharma will be discontinuing production of all rosuvastatin presentations.


Accord has rosuvastatin 40 mg tablets in 30 count and 1000 count bottles on back order and the company estimates a release date of mid-May 2019.

Biocon has all rosuvastatin presentations on back order and the company estimates a release date of early-May 2019.

Rising has all rosuvastatin presentations on allocation. Sun Pharma will be discontinuing production of rosuvastatin 5 mg, 10 mg, 20 mg, and 40 mg

tablets in 90 count bottles. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=473



Remifentanil Injection May 2, 2019 Reasons for the Shortage

Mylan Institutional did not provide a reason for the shortage. Fresenius Kabi launched generic remifentanil in January 2018.


Mylan Institutional has Ultiva 1 mg and 5 mg vials on back order and the company estimates a release date of mid-May 2019.

Fresenius Kabi has remifentanil 2 mg and 5 mg vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=371 Piperacillin and Tazobactam Injection May 2, 2019 Reasons for the Shortage

Apotex has piperacillin/tazobactam injection available. AuroMedics did not provide a reason for the shortage. Baxter has piperacillin/tazobactam injection available. Fresenius Kabi has piperacillin/tazobactam injection available. Mylan Institutional did not provide a reason for the shortage. Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing

delays. Sagent has piperacillin/tazobactam injection on shortage due to increased demand. Sandoz has piperacillin/tazobactam injection available. WG Critical Care has piperacillin/tazobactam injection available. Wockhardt has piperacillin/tazobactam injection available. X-Gen has piperacillin/tazobactam injection available.


Auromedics has piperacillin/tazobactam 3.375 gram vials on intermittent back order and the company is releasing supplies as they become available.

Mylan has piperacillin/tazobactam 4.5 gram vials on back order and the company estimates a release date of mid-May 2019.

Pfizer has Zosyn 2.25 gram vials, 3.375 gram vials, 4.5 gram vials, and 40.5 gram vials on back order and the company estimates a release date of March 2020. The piperacillin/tazobactam 2.25 gram ADD-Vantage vials are on back order and the company estimates a release date of July 2019.

Sagent has piperacillin/tazobactam 3.375 gram and 4.5 gram vials on back order and the company estimates a release date of May 2019. There are short-dated 2.25 gram vials available with an expiration date of October 2019.




Dobutamine Injection May 2, 2019 Reasons for the Shortage

Baxter has dobutamine available. Pfizer has dobutamine on shortage due to manufacturing delays.


Pfizer has dobutamine 12.5 mg/mL 20 mL and 40 mL latex-free vials on back order with an estimated release date of March 2020 for the 20 mL vials and December 2019 for the 40 mL vials.

Pfizer has dobutamine 4 mg/mL in 250 mL bags on back order and the company estimates a release date of June 2019. The dobutamine 1 mg/mL 250 mL bags are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=296 Cyclosporine Injection May 2, 2019 Reasons for the Shortage

Novartis has Sandimmune available. Perrigo has cyclosporine injection available.


Perrigo has cyclosporine 50 mg/mL 5 mL ampules available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=534 Cosyntropin Injection May 2, 2019 Reasons for the Shortage

Amphastar has Cortrosyn on shortage due to increased demand. Mylan Institutional did not provide a reason for the shortage. Sandoz did not provide a reason for the shortage.


Mylan Institutional has cosyntropin 0.25 mg vials on back order and the company estimates a release date of late-January 2020.

Amphastar has Cortrosyn 0.25 mg vials on intermittent back order with regular releases. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=522 Ceftazidime Injection May 2, 2019 Reasons for the Shortage

Pfizer has Tazicef available. Sagent has ceftazidime injection on shortage due to increased demand and manufacturing

delays. BBraun had ceftazidime on allocation due to increased demand. Teligent discontinued Fortaz 2 gram vials, 6 gram vials, and both 1 gram/50 mL and 2 gram/50

mL premixes in February 2018. They also discontinued the 1 gram and 2 gram Twistvials in April 2019.

WG Critical Care has ceftazidime available.




BBraun has ceftazidime 1 gram and 2 gram premixed bags on allocation Sagent has ceftazidime 2 gram vials on allocation. The 6 gram vials are on back order and the

company estimates a release date of May 2019. Teligent has Fortaz 500 mg vials and 1 gram vials on back order and the company estimates a

release date of September 2019. They discontinued the 1 gram and 2 gram TwistVials. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=63 Cefepime Injection May 2, 2019 Reasons for the Shortage

Apotex has cefepime injection available. Baxter has cefepime on allocation due to increased demand. BBraun has cefepime on shortage due to manufacturing delays. Fresenius Kabi has cefepime injection available. Pfizer has Maxipime on shortage due to manufacturing delays. Sagent has cefepime injection on shortage due to increased demand. Samson Medical Technologies has cefepime injection available. Sandoz discontinued cefepime injection in early-2016. WG Critical Care has cefepime injection available.


Baxter has cefepime 2 gram premixed bags on allocation.

BBraun has cefepime 1 gram and 2 gram premixed bags on allocation.

Pfizer has Maxipime 1 gram and 2 gram vials and 1 gram and 2 gram ADD-Vantage vials on back order and the company estimates a release date of August 2020.

Sagent has cefepime 2 gram vials on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=59 Amphetamine Mixed Salts, Immediate-Release Tablets May 2, 2019 Reasons for the Shortage

Aurobindo has amphetamine mixed salts available. Mallinckrodt has amphetamine mixed salts available. Mylan did not provide a reason for the shortage. Sun Pharma did not provide a reason for the shortage. Teva has Adderall and amphetamine mixed salts available. Zydus has amphetamine mixed salts available.


Mylan has all amphetamine mixed salts, immediate-release tablets on back order and the company estimates a release date of late-June 2019.

Sun Pharma has all amphetamine mixed salts, immediate-release tablets on back order and the company cannot estimate a release date.




Spironolactone Tablets May 3, 2019 Reasons for the Shortage

Accord, Amneal, Cadista, Mylan, and Sun Pharma did not provide a reason for the shortage. Par discontinued spironolactone tablets in August 2018. Pfizer states Aldactone is on shortage due to manufacturing delays.


Accord has spironolactone 50 mg and 100 mg tablets in 500 count bottles on back order and the company estimates a release date in early- to mid-May 2019.

Cadista has all presentations on allocation.

Mylan has spironolactone 50 mg tablets in 100 and 500 count bottles and 25 mg tablets in 100 count bottles on back order and the company estimates a release date of mid-June 2019 for the 25 mg and 50 mg tablets in 100 count bottles and late-May 2019 for the 50 mg tablets in 500 count bottles. The 50 mg tablets in 100 count unit-dose packs are on back order and the company estimates a release date of early-June 2019. The 100 mg tablets in 100 count unit-dose packs are on back order and the company cannot estimate a release date.

Pfizer has Aldactone 50 mg tablets in 100 count bottles on back order and the company estimates a release date of June 2019.

Sun Pharma has spironolactone 25 mg tablets in 100 and 1000 count, 50 mg tablets in 60 and 500 count, and 100 mg in 100 count on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=447 Sodium Phosphate Injection May 3, 2019 Reasons for the Shortage

American Regent is not currently marketing sodium phosphate injection. Fresenius Kabi states the reason for the shortage was increased demand. Pfizer has sodium phosphate injection on shortage due to manufacturing delay.


Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=227 Potassium Chloride Injection May 3, 2019 Reasons for the Shortage

Baxter had their highly concentrated potassium chloride in sterile water on shortage because a manufacturing facility was affected by Hurricane Maria. Baxter did not provide a reason for the shortage of their other potassium chloride products.

Fresenius Kabi did not provide a reason for the shortage.



Pfizer has potassium chloride injection on shortage due to increase demand. Pfizer discontinued 2 mEq/mL 250 mL bottles in mid-2018.

ICU Medical has potassium chloride injection on shortage due to increased demand. ICU Medical discontinued potassium chloride 10 mEq/500 mL in 5% dextrose and 0.225%

sodium chloride in 2018. Estimated Resupply Dates

All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=12 Norepinephrine Bitartrate Injection May 3, 2019 Reasons for the Shortage

Baxter has norepinephrine injection available. Pfizer has Levophed on shortage due to manufacturing delays. Teva had norepinephrine injection on allocation due to increased demand.


Pfizer has Levophed 1 mg/mL 4 mL ampules on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=292 Methocarbamol Tablets May 3, 2019 Reasons for the Shortage

Bayshore states the shortage is due to increased demand. Virtus, Hikma, and Endo did not provide a reason for the shortage. Camber states the shortage is due to an API shortage. Par discontinued methocarbamol tablets in July 2018. Solco states the shortage is due to an API shortage.


Camber has all methocarbamol tablets available for contracted customers. All presentations are on allocation for non-contracted customers.

Hikma has methocarbamol 500 mg and 750 mg tablets in 500 count on back order and the company estimates a release date of mid-May to early-June 2019. Methocarbamol 500 mg and 750 mg tablets in 100 count are on back order and the company cannot estimate a release date.

Solco has all methocarbamol presentations on allocation. Virtus has all methocarbamol tablets on back order and the company cannot estimate a release

date. Endo has Robaxin 750 mg tablets in 100 count on back order and the company cannot estimate

a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=423



Melphalan tablets May 3, 2019 Reasons for the Shortage

Apo-Pharma did not provide a reason for the shortage. Estimated Resupply Dates

Apo-Pharma has melphalan 2 mg tablets on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=472 Lidocaine Injection May 3, 2019 Reasons for the Shortage

Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand for the product.

AuroMedics introduced lidocaine injection in February 2014. Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of

raw ingredients. Pfizer has lidocaine presentations on shortage due to manufacturing delays.


Amphastar has 2% lidocaine 5 mL syringes on intermittent back order and the company is releasing product as it becomes available.

AuroMedics has 1% lidocaine 5 mL ampules and 5 mL vials on intermittent back order and the company is releasing product as it becomes available. AuroMedics has 2% lidocaine 5 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has 1% Xylocaine 20 mL vials on back order and the company estimates a release date of early-May 2019. The 1% Xylocaine-MPF 30 mL vials are on back order and the company estimates a release date of late-May 2019. The 1% lidocaine 2 mL vials are on back order and the company cannot estimate a release date. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF 10 mL ampules are on back order and the company cannot estimate a release date. The 2% Xylocaine 20 mL vials are on back order and the company estimates a release date of mid-May 2019. Check wholesalers for inventory.

Pfizer has 1% lidocaine 5 mL preservative-free ampules on back order and the company estimates a release date of March 2020. The 1% lidocaine 20 mL vials are available in limited supply. The 1% lidocaine 30 mL preservative-free vials are on back order and the company estimates a release date of May 2019. The 1% lidocaine 50 mL vials are on back order and the company estimates a release date of May 2019. The 1% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of August 2019. The 1.5% lidocaine 10 mL preservative-free ampules are on back order and the company cannot estimate a release date. The 1.5% lidocaine 20 mL preservative-free ampules are on back order and the company estimates a release date of July 2019. The 2% lidocaine 10 mL ampules are on back order and the company estimates a release date of June 2019. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of June 2019. The 2% lidocaine 20 mL vials are on intermittent back order and the company is releasing product as it becomes available. The 2% lidocaine 50 mL vials are available in limited supply. The 2% lidocaine 5 mL Lifeshield syringes



are on back order and the company estimates a release date of July 2019. The 4% lidocaine 5 mL ampules are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=88 Hydromorphone Hydrochloride Injection May 3, 2019 Reasons for the Shortage

Akorn has hydromorphone injection on shortage due to increased demand. Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing

their product on the 0.5 mg strength. They launched hydromorphone vials in late-June 2018. Pfizer did not provide a reason for the shortage. Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons. Teva did not provide a reason for the shortage. Hikma did not provide a reason for the shortage.


Fresenius Kabi has Dilaudid 2 mg/mL 1 mL syringes on back order and the company cannot estimate a release date. The hydromorphone 1 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-May 2019. The hydromorphone 10 mg/mL 1 mL vials are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has 2 mg/mL 1 mL vials available in limited supply. The 10 mg/mL 50 mL vials are on back order and the company estimates a release date of May 2019. The 10 mg/mL 5 mL vials are on back order and the company estimates a release date of May 2019. The 0.5 mg/0.5 mL iSecure syringes are on back order and the company estimates a release date of June 2019. The 2 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of May 2019. The 1 mg/mL 1 mL ampules, 2 mg/mL 1 mL ampules, and 4 mg/mL 1 mL ampules are on back order and the company estimates a release date of September 2019 for the 1 mL and 2 mL ampules and June 2019 for the 4 mL ampules. The 1 mg/mL 1 mL iSecure syringes, 2 mg/mL 1 mL iSecure syringes, and 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of September 2019.

Teva has 10 mg/mL 1 mL, 5 mL, and 50 mL vials on intermittent back order and the company is allocating upon release.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329 Fluorouracil Injection May 3, 2019 Reasons for the Shortage

Accord did not provide a reason for the shortage. Fresenius Kabi did not provide a reason for the shortage. Sagent has fluorouracil injection on shortage due to increased demand. Teva Adrucil injection available.


Sagent has fluorouracil 50 mg/mL 100 mL vials on back order and the company estimates a release date of May 2019.




Dorzolamide Ophthalmic Solution May 3, 2019 Reasons for the Shortage

Akorn has dorzolamide ophthalmic solution on shortage due to manufacturing delays. Merck did not provide a reason for the shortage. Sandoz did not provide a reason for the shortage. Teva discontinued dorzolamide ophthalmic solution in April 2018. Bausch Health had dorzolamide ophthalmic solution on shortage due to manufacturing delays.


Akorn has dorzolamide 2% ophthalmic solution in 10 mL bottles on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=359 Dopamine Hydrochloride Injection May 3, 2019 Reasons for the Shortage

American Regent is not marketing dopamine injection. Baxter had dopamine on shortage due to manufacturing delays. Pfizer states the shortage is due to manufacturing delays. The dopamine 200 mg/250 mL and

400 mg/500 mL premixed bags were discontinued in August 2017.

Estimated Resupply Dates Pfizer has dopamine 40 mg/mL 5 mL and 10 mL vials on back order and the company estimates a

release date of August 2019 for the 5 mL vials and December 2019 for the 10 mL vials. The 400 mg/250 mL premixed bags and 800 mg/250 mL premixed bags are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=246 Cefuroxime Sodium Injection May 3, 2019 Reasons for the Shortage

Sagent has cefuroxime injection on shortage due to manufacturing delays. Teligent discontinued all Zinacef presentations in February 2018. Hikma did not provide a reason for the cefuroxime injection shortage. They are not currently

marketing the 7.5 gram vials. Estimated Resupply Dates

Sagent has cefuroxime 750 mg and 1.5 gram vials on back order and the company cannot estimate a release date.

Hikma has cefuroxime 750 mg vials on back order and the company estimates a release date of early-May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=13 Butorphanol Tartrate Injection May 3, 2019 Reasons for the Shortage

Pfizer had butorphanol injection on shortage due to manufacturing delays. Estimated Resupply Dates



Pfizer has butorphanol injection available.


Bacteriostatic 0.9% Sodium Chloride Vials May 3, 2019 Reasons for the Shortage

Fresenius Kabi did not provide a reason for the shortage. Pfizer had bacteriostatic sodium chloride vials on shortage due to manufacturing delays.


Fresenius Kabi has bacteriostatic 0.9% sodium chloride 30 mL vials on back order and the company estimates a release date of late-May 2019.


Amiodarone Injection May 3, 2019 Reasons for the Shortage

Baxter has Nexterone premixed bags on shortage due to manufacturing delays. Mylan Institutional did not provide a reason for the shortage. Hikma did not provide a reason for the shortage; however, the 50 mg/mL, 3 mL 10 count

presentation was discontinued in December 2018. Estimated Resupply Dates

AuroMedics has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on intermittent back order and the company is releasing product as it becomes available.

Baxter has Nexterone 150 mg/100mL and 360 mg/200mL premixed bags on allocation. Fresenius Kabi has amiodarone 50 mg/mL 3 mL and 9 mL vials on back order and the company

estimates a release date of late-May 2019. Hikma has amiodarone 50 mg/mL 3 mL vials on allocation. Sagent has amiodarone 50 mg/mL 3 mL vials on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=374 Aminophylline Injection May 3, 2019 Reasons for the Shortage

Pfizer has aminophylline injection on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has aminophylline 25 mg/mL 20 mL vials on back order and the company estimates a release date of September 2019.




Promethazine Injection May 5, 2019 Reasons for the Shortage

Hikma did not provide a reason for the shortage. X-Gen has promethazine injection available.


Hikma has short-dated Phenergan 50 mg/mL 1 mL ampules available with an expiration date of August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=460 Letermovir Injection May 5, 2019 Reasons for the Shortage

Merck has Prevymis on shortage due to a supply disruption. Estimated Resupply Dates

Merck has Prevymis 20 mg/mL 12 mL and 24 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=487 Diltiazem Hydrochloride Injection May 5, 2019 Reasons for the Shortage

Akorn states the reason for the shortage was increased demand due to market conditions. They are not currently producing the 25 mL vials in 10 count.

Pfizer states the reasons for the shortage is manufacturing delays and increases in demand. Hikma has diltiazem injection on shortage due to manufacturing delays caused by increased

demand due to current market conditions. Estimated Resupply Dates

Hikma has diltiazem 5 mg/mL 25 mL vials on allocation. Pfizer has 100 mg ADD-Vantage vials on back order and the company estimates a release date of

May 2019. The 5 mg/mL 5 mL and 10 mL vials are also on back order and the company estimates a release date of March 2020 for the 5 mL vials and September 2019 for the 10 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26 Deferoxamine Injection May 5, 2019 Reasons for the Shortage

Fresenius Kabi had deferoxamine on shortage due to increased demand. Pfizer has deferoxamine on shortage due to manufacturing delays. Novartis has Desferal available. Alvogen did not provide a reason for the shortage. Alvogen launched deferoxamine injection in

mid-2018. Apo-Pharma launched deferoxamine injection in mid-2018.



Estimated Resupply Dates Alvogen has deferoxamine 500 mg vials available with short expiration dating (January 2020). Pfizer has deferoxamine 500 mg vials on back order and the company estimates a release date

of June 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=393 Copper Chloride Injection May 5, 2019 Reasons for the Shortage

Pfizer has copper chloride on shortage due to manufacturing delays. They are the sole supplier of copper chloride.


Pfizer has copper chloride available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=553 Vancomycin Hydrochloride Injection May 6, 2019 Reasons for the Shortage

Alvogen has vancomycin injection available. Athenex has vancomycin injection available. AuroMedics did not provide a reason for the shortage. Pfizer has vancomycin vials on back order due to manufacturing delays. Fresenius Kabi has vancomycin injection available. Mylan Institutional has vancomycin injection available. Baxter has vancomycin injection available. Samson Medical Technologies has vancomycin injection available. Sagent has vancomycin injection available. Xellia Pharmaceuticals has vancomycin injection available.


Alvogen has vancomycin 500 mg vials on back order and the company estimates a release date of mid-May 2019.

Athenex has vancomycin 500 mg vials on back order and the company estimates a release date of May 2019.

AuroMedics has vancomycin 1 gram vials on long-term back order and the company cannot estimate a release date.

Baxter has all vancomycin presentations on allocation. Pfizer has 500 mg ADD-Vantage vials, 500 mg vials, 750 mg vials, 750 mg ADD-Vantage vials, and

1 gram vials available in limited supply. The 1 gram ADD-Vantage vials are on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 Orphenadrine Citrate Injection May 6, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage. Hikma did not provide a reason for the shortage.



Teva discontinued orphenadrine in November 2018. Estimated Resupply Dates

Hikma has orphenadrine 30 mg/mL 2 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=471 Heparin Sodium Premixed Bags May 6, 2019 Reasons for the Shortage

Baxter has heparin on shortage due to manufacturing delays. BBraun has heparin premixes available. Fresenius Kabi has heparin premixes available. Pfizer has heparin on shortage due to manufacturing delays.


Baxter has heparin 2000 units/1,000 mL premixed bags on back order and the company cannot estimate a release date.

Fresenius Kabi has heparin 25,000 units/250 mL 5% dextrose premixed bags on back order and the company estimates a release date of mid-May 2019.

Pfizer has heparin 2,000 units/1,000 mL 0.9% sodium chloride premixed bags on back order and the company estimates a release date of May 2019. The 25,000 units/250 mL 0.45% sodium chloride premixed bags and 25,000 units/250 mL 5% dextrose premixed bags are on back order and the company estimates a release date of May 2019. Heparin 1,000 units/500 mL 0.9% sodium chloride premixed bags are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=468 Fluvastatin Capsules May 6, 2019 Reasons for the Shortage

Mylan did not provide a reason for the shortage. Teva did not provide a reason for the shortage.


Mylan has fluvastatin 20 mg and 40 mg capsules in 30 count and 90 count on back order and the company estimates a release date of mid-September 2019.

Teva has fluvastatin 20 mg and 40 mg capsules in 100 count on back order and the company estimates a release date of late-September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=561 Ampicillin Sodium and Sulbactam Injection May 6, 2019 Reasons for the Shortage

Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-Vantage vials.

Sagent has ampicillin sulbactam vials on back order due to manufacturing delays and increased demand.

Sandoz cannot provide a reason for the shortage. WG Critical Care states the shortage is due to increased demand.




AuroMedics has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Fresenius Kabi has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Hikma has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company cannot estimate a release date.

Mylan Institutional has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company estimates a release date of mid-May 2019 for the 1.5 and 3 gram vials and mid-July 2019 for the 15 gram vials.

Pfizer has Unasyn 15 gram vials available in limited supply. Unasyn 1.5 gram and 3 gram bulk vials are on back order and the company estimates a release date of July 2019. The 3 gram ADD-Vantage vials are on back order and the company estimates a release date of July 2019.

Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Sagent has ampicillin sulbactam 1.5 gram vials and 15 gram bulk vials on back order and the company cannot estimate a release date. The 3 gram vials are on back order and the company estimates a release date of June 2019.

WG Critical Care has ampicillin sulbactam 1.5 gram and 3 gram vials on back order and the company estimates a release date of late-May 2019. The 15 gram bulk vials are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 Amphotericin B Injection May 6, 2019 Reasons for the Shortage

X-Gen had amphotericin B on shortage due to manufacturing delays. They are the sole suppliers of amphotericin B lyophilized powder for injection.

Lipid-based amphotericin is not affected by this shortage. Estimated Resupply Dates

X-Gen has amphotericin B 50 mg vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=524 Alcohol Dehydrated Injection (Ethanol) May 6, 2019 Reasons for the Shortage

Akorn states the back order was due to manufacturing delays. American Regent is not currently marketing dehydrated alcohol. Flon Laboratories has dehydrated alcohol 1 mL and 5 mL vials available through Morris and

Dickson and direct orders. The customer service number is 877-358-4342. It is being marketed by MHC Pharma, LLC.

BPI has Ablysinol available. It is the only FDA-approved dehydrated alcohol product currently marketed.


All marketed presentations are available.



https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=274 Mycophenolate Mofetil Capsules and Tablets May 7, 2019 Reasons for the Shortage

Accord did not provide a reason for the shortage. Ascend did not provide a reason for the shortage. Hikma did not provide a reason for the shortage. Mylan did not provide a reason for the shortage. Genentech has Cellcept available. Sandoz did not provide a reason for the shortage.


Accord has all mycophenolate mofetil presentations on allocation. Ascend has all mycophenolate mofetil presentations on intermittent back order and the

company is releasing product as it becomes available. Hikma has mycophenolate mofetil 250 mg capsules in 100 count and 500 count and 500 mg

tablets in 100 count and 500 count on allocation. Mylan has mycophenolate mofetil 250 mg capsules in 500 count on back order and the company

estimates a release date of mid-June 2019. The 500 mg tablets in 500 count are on back order and the company estimates a release date of late-May 2019. The 250 mg capsules and 500 mg tablets in unit-dose blister packs are on back order and the company estimates a release date of early-July 2019.

Sandoz has mycophenolate mofetil 250 mg capsules in 1440 count are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=448 Methadone Injection May 7, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage. Mylan Institutional has methadone injection available.


All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=358 Hyoscyamine Sulfate Injection May 7, 2019 Reasons for the Shortage

Mylan did not provide a reason for the shortage. Estimated Resupply Dates

Mylan Institutional has Levsin 0.5 mg/mL 1 mL ampules on back order and the company cannot estimate a release date.




Diclofenac Potassium Tablets May 7, 2019 Reasons for the Shortage

Mylan did not provide a reason for the shortage. Teva did not provide a reason for the shortage. Sandoz discontinued diclofenac potassium tablets.


Mylan has diclofenac potassium 50 mg tablets on back order and the company estimates a release date of early- to mid-July 2019.

Teva has diclofenac potassium 50 mg tablets in 100 count and 500 count on back order and the company estimates a release date of early-June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=537 Clotrimazole Lozenges (Clotrimazole Troches) May 7, 2019 Reasons for the Shortage

Hikma did not provide a reason for the shortage. Perrigo has clotrimazole lozenges on shortage due to increased demand.


Hikma has clotrimazole 10 mg lozenges in 70 count and 140 count bottles on allocation. The 10 mg lozenges in 70 count unit-dose packs are on allocation.

Perrigo has clotrimazole 10 mg lozenges in 70 count bottles on allocation. The 10 mg lozenges in 140 count bottles are on back order and the company estimates a release date of late-July 2019. The 10 mg lozenges in 70 count unit-dose packs are on back order and the company estimates a release date of late-July 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=541 Levetiracetam Immediate-Release Tablets May 8, 2019 Reasons for the Shortage

Accord has levetiracetam immediate-release tablets available. Aurobindo did not provide updated availability information. Camber has most presentations available. Lupin did not provide a reason for the shortage. Major has levetiracetam immediate-release tablets available. Mylan did not provide a reason for the shortage. OWP did not provide a reason for the Roweepra shortage. Torrent did not provide a reason for the shortage. UCB has Keppra immediate-release tablets available.


Camber has levetiracetam 500 mg immediate-release tablets in 500 count on intermittent back order and the company is allocating product as it becomes available.

Lupin has levetiracetam immediate-release tablets on allocation. Mylan has levetiracetam 250 mg immediate-release tablets in all sizes on back order and the

company cannot estimate a release date. The 500 mg tablets in 500 count are on back order and



the company estimates a release date of mid-May 2019. The 500 mg and 750 mg immediate-release tablets in 100 count unit dose packages are on back order and the company estimates a release date in early-June 2019. The 1000 mg immediate-release tablets in 50 count unit dose packages and 60 count bottles are on back order and the company estimates a release date of late-July to early-August 2019 for the 50 count unit dose packages and mid-July 2019 for the 60 count bottles.

OWP has Roweepra immediate-release tablets on back order and the company cannot estimate a release date.

Torrent has levetiracetam immediate-release tablets on allocation https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=533 Hypromellose Ophthalmic Solution May 8, 2019 Reasons for the Shortage

Akorn has hypromellose ophthalmic solution on shortage due to lack of raw materials. HUB Pharmaceuticals has hypromellose ophthalmic solution on long-term back order and did

not provide a reason. Altaire did not provide a reason for the shortage. OcuSoft has Goniosoft available.


Akorn has Gonak 2.5% ophthalmic solution 15 mL bottles on allocation. HUB Pharmaceuticals has Goniovisc 2.5% ophthalmic solution 15 mL bottles on long-term back

order and the company cannot estimate a release date. Altaire has Goniotaire on back order and the company estimates a release date in mid-May

2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=437

Desiccated Thyroid Tablets May 8, 2019 Reasons for the Shortage

Acella has NP Thyroid available. Allergan has Armour Thyroid available. RLC states the reason for the shortage is increased demand and difficulty obtaining raw

materials. Estimated Resupply Dates

RLC has Nature-Throid 16.25 mg, 194.4 mg, 260 mg, and 325 mg tablets on back order and the company cannot estimate a release date. Westhroid presentations are also on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=350 Ciprofloxacin Oral Suspension May 8, 2019 Reasons for the Shortage

Lupin did not provide a reason for the shortage. Bayer has Cipro oral suspension available.



Estimated Resupply Dates Lupin has ciprofloxacin oral suspension on long-term back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=255 Cefazolin Injection May 8, 2019 Reasons for the Shortage

Apotex has discontinued all presentations except cefazolin 1 gram vials. Baxter did not provide a reason for the shortage. BBraun has cefazolin on shortage due to manufacturing delays. Fresenius Kabi has cefazolin on shortage due to increased demand. They are not manufacturing

the 20 gram vials at this time to focus on the other sizes. Hikma did not provide a reason for the shortage. Pfizer states the reason for the shortage is manufacturing delay. Sagent states the reason for the shortage is manufacturing delays and increased demand. Samson Medical Technologies has cefazolin injection available. Sandoz has cefazolin injection available. WG Critical Care did not provide a reason for the shortage.


Baxter has cefazolin 2 gram/100 mL premixed bags on allocation. BBraun has 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation. Fresenius Kabi has cefazolin 500 mg vials and 1 gram vials on back order and the company

estimates a release date of mid-May 2019 for the 500 mg vials and late-May 2019 for the 1 gram vials. The 10 gram vials are on back order and the company estimates a release date of 4th quarter 2019.

Hikma has cefazolin 500 mg vials on back order and the company estimates a release date of May 2019. The 1 gram and 10 gram vials are on allocation.

Pfizer has 1 gram and 10 gram vials on back order and the company estimates a release date of March 2021. The 1 gram ADD-Vantage vials are on allocation.

Sagent has cefazolin 500 mg, 1 gram, and 10 gram vials on intermittent back order and the company will release product on a monthly basis.

WG Critical Care has cefazolin 500 mg vials on back order and the company cannot estimate a release date. The 10 gram vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=432 0.9% Sodium Chloride Small Volume Bags (<150ml) May 8, 2019 Reasons for the Shortage

Baxter did not provide a reason for the 0.9% sodium chloride small volume bags shortage. Most presentations are available.

BBraun has 0.9% sodium chloride small volume bags available. BD has 0.9% sodium chloride small volume bags available. Fresenius Kabi has 0.9% sodium chloride small volume bags available. ICU Medical has 0.9% sodium chloride small volume bags available. Pfizer has 0.9% sodium chloride small volume presentations on shortage due to increased

demand.




ICU Medical has 0.9% sodium chloride bags readily available except the 0.9% sodium chloride 100 mL VisIV bags are available to current customers only.

Pfizer has 0.9% sodium chloride 50 mL preservative-free vials on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=352 Doxycycline Hyclate Injection May 9, 2019 Reasons for the Shortage

Mylan Institutional did not provide a reason for the shortage. Zydus did not provide a reason for the shortage.


Mylan Institutional has doxycycline 100 mg vials on back order and the company estimates a release date of mid- to late-June 2019.

Zydus has doxycycline 100 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=559 Dexmedetomidine Hydrochloride 100mcg/ml Vials for Injection May 9, 2019 Reasons for the Shortage

Accord has dexmedetomidine vials available. Akorn has dexmedetomidine vials available. Athenex has dexmedetomidine vials available. AuroMedics has dexmedetomidine vials available. Fresenius Kabi has dexmedetomidine vials available. Hikma has dexmedetomidine vials available. Mylan did not provide a reason for the shortage. Par has dexmedetomidine vials available. Pfizer has dexmedetomidine vials available. Sandoz has dexmedetomidine vials available. Sun Pharma is no longer manufacturing dexmedetomidine. Teva did not provide a reason for the temporary discontinuation of dexmedetomidine vials. WG Critical Care has dexmedetomidine vials on back order due to manufacturing delays.


Teva has temporarily discontinued dexmedetomidine 100 mcg/mL 2 mL vials and the company cannot estimate a resupply date.

WG Critical Care has dexmedetomidine 100 mcg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of mid-May 2019.




Sulfanilamide Cream May 13, 2019 Reason for the Shortage

Mylan did not provide a reason for the shortage. They are the sole suppliers of sulfanilamide

cream.


Mylan has AVC Cream on back order and the company cannot estimate a release date.


Ranitidine Injection May 13, 2019 Reason for the Shortage

Mylan has ranitidine injection available.

Teligent had Zantac IV on shortage due to production delays.

Zydus has ranitidine injection available.


All marketed presentations are available

Losartan and Hydrochlorothiazide Tablets


Losartan and Hydrochlorothiazide Tablets May 13, 2019 Reason for the Shortage

Alembic did not provide a reason for the shortage.

Aurobindo refused to provide updated availability information

Cadista did not provide a reason for the shortage.

Lupin did not provide a reason for the shortage.

Merck has Hyzaar tablets available.

Rising did not provide a reason for the shortage.

Sandoz recalled one lot of losartan and hydrochlorothiazide 100 mg/25 mg tablets in 1000

count bottles in November 2018 due to an impurity found in the active pharmaceutical

ingredient. Additional information can be found at

https://www.fda.gov/Safety/Recalls/ucm625492.htm.

Torrent recalled certain lots of losartan and hydrochlorothiazide 50 mg/ 12.5 mg tablets in

90 and 1000 count bottles and 100 mg/ 12.5 mg tablets in 90 and 1000 count bottles in

December 2018, January 2019, March 2019, and April 2019 due to an impurity found in the

active pharmaceutical ingredient. Additional information can be found at

https://www.fda.gov/Safety/Recalls/ucm629693.htm and

https://www.fda.gov/Safety/Recalls/ucm636296.htm.

Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots

unaffected by the recall).



Teva did not provide a reason for the shortage.


Alembic has losartan and hydrochlorothiazide tablets on allocation to contracted customers

Cadista has losartan and hydrochlorothiazide tablets on back order and the company cannot

estimate a release date.

Lupin has losartan and hydrochlorothiazide tablets on intermittent back order and the

company is allocating supplies as they become available.

Rising has losartan and hydrochlorothiazide tablets on back order and the company cannot


Sandoz has losartan and hydrochlorothiazide tablet presentations on back order and the

company cannot estimate a release date.

Teva has losartan and hydrochlorothiazide 50 mg/12.5 mg tablets in 30, 90, and 1000 count

bottles and 100 mg/12.5 mg tablets in 90 count bottles on back order and the company

estimates a release date in early-June 2019. The 100 mg/12.5 mg tablets in 30 count and

1000 count bottles are on back order and the company estimates a release date in late-May

2019. The 100 mg/25 mg tablets in 30, 90, and 1000 count bottles are on back order and the

company estimates a release date in late-June 2019.


Lorazepam Tablets

May 13, 2019

Reason for the Shortage

Aurobindo refuses to provide availability information.

Leading has lorazepam tablets on shortage due to increased demand.

Major did not provide a reason for the shortage.

Mylan has discontinued all bottled presentations.

Mylan Institutional discontinued all unit-dose blister pack presentations.

Sandoz discontinued all lorazepam presentations.

Teva has lorazepam tablet presentations available.


Leading has all lorazepam tablets on allocation.

Major has lorazepam 0.5 mg, 1 mg, and 2 mg tablets in 100 count bottles on intermittent

back order and the company is releasing supplies as they become available. The 0.5 mg and

1 mg tablets in 100 count unit-dose packages are on back order and the company estimates

a release date in mid-June 2019. The 2 mg tablets in 100 count unit-dose packages are

available in limited supply.




Indomethacin Capsules

May 13, 2019


•Camber did not provide a reason for the shortage.

•Glenmark has indomethacin on shortage due to manufacturing delays.

•Heritage discontinued all indomethacin presentations in early-2018.

•Mylan did not provide a reason for the shortage. Mylan is in the process of discontinuing all presentations.

•Sandoz discontinued indomethacin in mid-2016.

•Teva discontinued all indomethacin presentations in mid-2018. Estimated Resupply Dates

Camber has indomethacin 25 mg and 50 mg capsules available to contracted customers.

Glenmark has indomethacin 25 mg capsules in 100 count and 1,000 count and 50 mg capsules in

100 count and 500 count on back order and the company estimates a release date of mid-May

2019.


Fluticasone and Salmeterol Powder for Inhalation

May 13, 2019


Teva Respiratory did not provide a reason for the shortage.

Other fluticasone and salmeterol dry powder inhalers are not affected by the shortage. Estimated Resupply Dates

Teva Respiratory has AirDuo Respiclick 113 mcg/14 mcg on back order and the company estimates a release date in late-May 2019.

Teva Respiratory has fluticasone and salmeterol 113 mcg/14 mcg and 232 mcg/14 mcg dry powder inhalers on back order and the company estimates a release date of late-June 2019 for the 113 mcg/14 mcg inhalers and early-June 2019 for the 232 mcg/14 mcg inhalers. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=544

Fluconazole Injection

May 13, 2019


Baxter has fluconazole injection available.

Hikma discontinued fluconazole injection in August 2018.

Pfizer had fluconazole injection on shortage due to manufacturing delays. The 200 mg/100 mL fluconazole in dextrose bags were discontinued in August 2018.

Renaissance Lakewood Pharmaceuticals bought fluconazole in sodium chloride premixed bags from Claris Lifescience.



Sagent had fluconazole injection on shortage due to increased demand and manufacturing delays.


Renaissance Lakewood has fluconazole 200 mg/100 mL in 0.9% sodium chloride 10 count premixes and 400 mg/200 mL in 0.9% sodium chloride 6 and 10 count premixes on back order and the company cannot estimate release dates.


Famotidine Injection

May 13, 2019


Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.


Pfizer launched famotidine injections in March 2012.

Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013.


Baxter did not provide a reason for the shortage. Estimated Resupply Dates

Baxter has famotidine 20 mg/50 mL premixed bags on intermittent back order and the company is releasing product regularly. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=166

Exenatide Extended-Release Suspension for Injection

May 13, 2019


AstraZeneca has Bydureon BCise available.

AstraZeneca has Bydureon Pen available. Estimated Resupply Dates

None Listed https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=548

Daptomycin Injection

May 13, 2019


Fresenius Kabi has daptomycin available.

Mylan Institutional did not provide a reason for the shortage.

Pfizer has daptomycin on shortage due to manufacturing delays.

Teva has daptomycin available.

Sagent has daptomycin on shortage due to manufacturing delays.



Merck has Cubicin and Cubicin RF available.

Xellia Pharmaceuticals has daptomycin available. Estimated Resupply Dates

Mylan Institutional has daptomycin 500 mg vials on back order and the company estimates a release date of mid- to late-June 2019.

Pfizer has daptomycin 500 mg vials on back order and the company estimates a release date of March 2020.

Sagent has daptomycin in 1 count and 10 count on back order and the company estimates a release date of June 2019 for the 1 count presentation and May 2019 for the 10 count presentation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=467

Clomiphene Citrate Tablets

May 13, 2019


Par did not provide a reason for the shortage. They are the sole suppliers of clomiphene citrate tablets.


Par has clomiphene citrate 50 mg tablets in 30 count unit-dose packs on back order and the company estimates a release date of early-June 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=538

Ascorbic Acid Injection

May 13, 2019


Mylan Institutional did not provide a reason for the shortage. Estimated Resupply Dates

Mylan Institutional has ascorbic acid 500 mg/mL 50 mL vials on back order and the company estimates a release date of mid-May 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=531

Tropicamide 1% Ophthalmic Solution

May 14, 2019


Akorn did not provide a reason for the shortage.

Alcon has Mydriacyl available.

Bausch Health discontinued tropicamide 1% ophthalmic drops in mid-2018.

Sandoz did not provide a reason for the shortage.




Sandoz has tropicamide 1% solution in 3 mL bottles on back order and the company estimates a release date of late-May 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=547

Tobramycin Sulfate Injection

May 14, 2019


Akorn discontinued tobramycin injection in late-2018.

Pfizer had tobramycin injection on shortage due to manufacturing delays.

Teva discontinued tobramycin 40 mg/mL 30 mL vials in June 2018. Estimated Resupply Dates

Mylan Institutional has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company estimates a release date of mid-May 2019.

Teva has temporarily discontinued tobramycin 40 mg/mL 2 mL vials. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=164

Methotrexate Injection

May 14, 2019


Accord has methotrexate injection on back order due to increased demand.

Fresenius Kabi has methotrexate injection available.

Mylan Institutional did not provide a reason for the shortage. Mylan Institutional discontinued the 40 mg/mL 2 mL, 4 mL, and 8 mL vials in late-2017.

Pfizer has methotrexate injection available.

Teva has methotrexate injection available.

Hikma has methotrexate injection available. Estimated Resupply Dates

Accord has methotrexate 25 mg/mL 40 mL preservative-free vials on back order and the company estimates a release date of late-May 2019.

Mylan Institutional has methotrexate 25 mg/mL 10 mL preservative-free vials on back order and the company estimates a release date in August 2019.


Lorazepam Injection

May 14, 2019


Bedford discontinued lorazepam injection in May, 2011.

Hikma has product on shortage due to manufacturing delays.




Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer discontinued 4 mg/mL 10 mL vials in December 2017.

Akorn has not provided a reason for the shortage.

Amphastar has product available. Estimated Resupply Dates

Hikma has Ativan 2 mg/mL 10 mL vials on back order and the company estimates a release date of May 2019.

Pfizer has lorazepam 2 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of June 2019. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of May 2019. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of March 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87

Indocyanine Green

May 14, 2019


Akorn had IC-Green on shortage due to manufacturing delays.

Hub has indocyanine green available. Estimated Resupply Dates

•All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=324

Immune Globulin, Intravenous or Subcutaneous (Human)

May 14, 2019


Baxalta has HyQvia and Cuvitru on shortage due to increased demand.

CSL Behring has Hizentra available.

Grifols has Gamunex-C and Flebogamma on shortage due to increased demand.

Kedrion Biopharma has Gammaked on shortage due to increased demand.

Takeda has Gammagard Liquid on shortage due to increased demand. Estimated Resupply Dates

Baxalta has Cuvitru and HyQvia on allocation and the company is reviewing all orders.

Grifols has all Gamunex-C and Flebogamma presentations on intermittent back order and the company is releasing product as it becomes available.

Kedrion Biopharma has all Gammaked presentations on back order and the company estimates a release date of late-May 2019.

Octapharma has all Octagam presentations on allocation.

Takeda has all Gammagard Liquid presentations on intermittent back order and the company is allocating product as it becomes available.




Heparin Injection

May 14, 2019


Fresenius Kabi has heparin on shortage due to increased demand.


Mylan did not provide a reason for the shortage.

Pfizer did not provide a reason for the shortage.

Sagent has heparin on shortage due to manufacturing issues and increased demand. Estimated Resupply Dates

Fresenius Kabi has heparin 10,000 unit/mL 5 mL vials on back order and the company estimates a release date of late-May 2019. The 10,000 unit/mL 4 mL vials are on back order and the company cannot estimate a release date.

Hikma has 1,000 unit/mL 30 mL vials and 5,000 unit/mL 10 mL vials on back order and the company cannot estimate a release date. The 1,000 unit/mL and 5,000 unit/mL 2 mL vials are on back order and the company estimates a release date of May 2019. The 10,000 unit/mL 2 mL vials are on allocation.

Mylan has 1,000 unit/mL 10 mL vials and 5,000 unit/mL 1 mL vials on back order and the company estimates a release date in mid-May 2019. The 10,000 unit/mL 4 mL vials and 20,000 unit/mL 1 mL vials are on back order and the company estimates a release date in October 2019.

Pfizer has 5,000 unit/mL 1 mL Carpuject syringes and 10,000 unit/mL 1 mL glass vials on back order and the company estimates a release date of June 2019. The 1,000 unit/mL 10 mL vials are on back order and the company cannot estimate a release date. The 1,000 unit/mL 1 mL glass vials, 5,000 unit/mL 1 mL glass vials, and 10,000 unit/mL 0.5 mL carpuject syringes are on back order and the company estimates a release date of May 2019. The 5,000 unit/mL 10 mL vials are on back order and the company estimates a release date in December 2019.

Sagent has 1,000 unit/mL 1 mL vials, 1,000 unit/mL 2 mL vials, 1,000 unit/mL 10 mL vials, and 20,000 unit/mL 1 mL vials on allocation. The 5,000 unit/mL 1 mL vials, 5,000 unit/mL 10 mL vials, 10,000 unit/mL 1 mL vials, and 10,000 unit/mL 4 mL vials are on back order and the company estimates a release date of June 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=353

Guanfacine Hydrochloride Tablets

May 14, 2019


Amneal did not provide a reason for the shortage.


Teva did not provide a reason for the shortage. Estimated Resupply Dates

Mylan has guanfacine 1 mg and 2 mg tablets in 100 count bottles on back order and the company estimates a release date of late-October 2019.



Teva has guanfacine 1 mg and 2 mg tablets in 100 count bottles on back order and the company cannot estimate a release date.


Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution

May 14, 2019


Akorn has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays.


Teva discontinued dorzolamide and timolol ophthalmic solution in April 2018.

Bausch Health has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays.


Akorn has Cosopt 2%/0.5% ophthalmic solution in 10 mL bottles and dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles on allocation.

Bausch Health has dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles on back order and the company estimates a release date of mid-June 2019.

Sandoz has dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles on back order and the company estimates a release date of May 2019.


Diltiazem Extended-Release Capsules (Twice-Daily Dosing)

May 14, 2019


Mylan did not provide a reason for the shortage. Estimated Resupply Dates

Mylan Institutional has diltiazem extended-release 90 mg capsules in 100 count unit-dose packs on back order and the company estimates a release date of mid-May 2019.


Dexrazoxane Injection

May 14, 2019


Cumberland Pharmaceuticals relaunched Totect in late-July 2017.



Pfizer states manufacturing delay as the reason for the shortage. Estimated Resupply Dates



Mylan Institutional has dexrazoxane 250 mg and 500 mg vials on back order and the company estimates a release date of late-May 2019.

Pfizer has Zinecard 500 mg vials on back order and the company estimates a release date of December 2019.

Hikma has short-dated dexrazoxane 500 mg vials available with an expiration date of < March 2020.


Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection

May 14, 2019


American Regent had betamethasone acetate/betamethasone sodium phosphate on shortage due to minor shipping delays.

Merck did not provide a reason for the shortage.

Exela Pharma Sciences has betamethasone acetate/betamethasone sodium phosphate on shortage due to increased demand.


Exela has betamethasone acetate/betamethasone sodium phosphate 6 mg/mL 5 mL vials on allocation.

Merck has Celestone Soluspan 5 mL vials on back order and the company estimates a release date of late-July 2019.


Atropine Ophthalmic Solution

May 14, 2019


Akorn did not provide a reason for the atropine ophthalmic solution shortage.

Altaire has homatropine ophthalmic solution available. Estimated Resupply Dates

Akorn has atropine ophthalmic solution available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=514

Thrombin Topical Powder (Recombinant)

May 15, 2019


Baxter did not provide a reason for the shortage. Estimated Resupply Dates

Baxter has Recothrom 20,000 unit pump spray kits on back order and the company cannot





Thiamine Injection

May 15, 2019


Fresenius Kabi has thiamine injection on shortage due to short manufacturing delay.

Mylan Institutional has thiamine injection available. Estimated Resupply Dates

Fresenius Kabi has thiamine 100 mg/mL 2 mL vials on back order and the company estimates a release date of late-May 2019.

Mylan Institutional has thiamine 100 mg/mL 2 mL vials on back order and the company estimates a release date of mid-May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=502 Sterile Water for Injection - Small Volume Vials

May 15, 2019


American Regent has sterile water for injection available.

Fresenius Kabi had sterile water on shortage due to increased demand.

Hikma has sterile water for injection available.

Pfizer has sterile water for injection in vials on shortage due to increased demand. Estimated Resupply Dates

Pfizer has sterile water for injection 100 mL vials on back order and the company estimates a release date of May 2019. The 20 mL vials are on intermittent back order and the company is releasing product as it becomes available.


Sodium Polystyrene Sulfonate Powder

May 15, 2019


CMP Pharma has sodium polystyrene sulfonate on back order due to a raw material shortage. They are using available powder to make suspension.

ECI Pharmaceuticals did not provide a reason for the shortage.

KVK-Tech did not provide a reason for the shortage.

Sunrise Pharmaceuticals has sodium polystyrene sulfonate on back order due to a raw material shortage.

Trigen did not provide a reason for the shortage. Estimated Resupply Dates



CMP Pharma has sodium polystyrene sulfonate in 454 gram bottles on back order and the company cannot estimate a release date.

ECI Pharmaceuticals has sodium polystyrene sulfonate in 454 gram bottles on allocation.

Sunrise Pharmaceuticals has sodium polystyrene sulfonate in 15 gram and 454 gram bottles on intermittent back order and the company cannot estimate release dates.

Trigen has sodium polystyrene sulfonate in 454 gram bottles on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=523

Sodium Bicarbonate Injection

May 15, 2019


Amphastar has sodium bicarbonate injection on shortage due to increased demand.

Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays.

Fresenius Kabi had sodium bicarbonate injection temporarily available, but have run out of stock, there is more in production at this time.


Amphastar has 8.4% sodium bicarbonate 50 mL syringes on allocation.

Fresenius Kabi has 8.4% sodium bicarbonate 50 mL vials on back order and the company estimates a release date of early-June 2019.

Pfizer has 4.2% sodium bicarbonate 10 mL LifeShield syringes, 7.5% sodium bicarbonate 50 mL syringes, and 8.4% sodium bicarbonate 10 mL syringes and 50 mL vials available in limited supply. The 8.4% 50 mL LifeShield syringes are on back order and the company estimates a release date of August 2019.

Pfizer has Neut 4% 5 mL vials on back order and the company estimates a release date of December 2019.


Sincalide Injection

May 15, 2019


Bracco Diagnostics has Kinevac injection on shortage due to a supply disruption.

There are no approved alternatives to Kinevac for the labeled indications. Estimated Resupply Dates

Bracco has Kinevac on backorder and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=277



RimabotulintoxinB Intramuscular Injection

May 15, 2019


Solstice Neurosciences, Inc. did not provide a reason for the shortage. Estimated Resupply Dates

•Solstice Neurosciences, Inc. has Myobloc 5000 unit/mL 0.5 mL vials on back order and the company estimates a release date in early-July 2019.


Recombinant Zoster Vaccine (Shingrix)

May 15, 2019


GlaxoSmithKline has Shingrix on shortage due to high demand for the product. Estimated Resupply Dates

GlaxoSmithKline has Shingrix on intermittent back order and the company is shipping orders according to order date and supply available.


Prednisone Oral Tablets

May 15, 2019


Cadista, Hikma, Par, and Teva did not provide a reason for the shortage. Estimated Resupply Dates

Cadista has prednisone 1 mg and 5 mg tablet presentations on allocation. The 10 mg and 20 mg tablet presentations are on intermittent back order and the company is allocating product as it becomes available.

Hikma has prednisone 5 mg tablets in 100 count bottles on back order and the company estimates a release date in mid- to late-May 2019. The 5 mg tablets in 1000 count bottles are on intermittent back order and the company is releasing supplies as they become available. Prednisone 10 mg and 20 mg tablets in 500 count bottles are on back order and the company estimates a release date in late-May to early-June 2019. Several other presentations are on allocation.

Par has prednisone 20 mg tablet presentations on back order and the company cannot estimate a release date.

Teva has prednisone 5 mg and 10 mg in 21 and 48 count unit dose packages on back order and the company estimates a release date in late-May 2019. The 20 mg in 100 count, 500 count, and 1000 count bottles are on back order and the company estimates a release date in late-May 2019 for the 100 count bottles, mid-June 2019 for the 500 count bottles, and early-June 2019 for the 1000 count bottles.




Potassium Acetate Injection

May 15, 2019


American Regent has not had product available for several years. It is unclear if they will market potassium acetate again in the future.

Pfizer has potassium acetate on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has potassium acetate 2 mEq/mL 50 mL vials on back order and the company estimates a release date of August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=344 Nystatin Oral Suspension May 15, 2019 Reason for the Shortage


Pharmaceutical Associates, Inc. did not provide a reason for the shortage.

Precision Dose has nystatin suspension on allocation due to increased demand.

Vista Pharma has nystatin suspension available.

Wockhardt USA did not provide a reason for the shortage. Estimated Resupply Dates

Akorn has nystatin 100,000 unit/mL suspension 60 mL and 473 mL bottles on back order and the company cannot estimate a release date.

Pharmaceutical Associates, Inc. has all nystatin suspension presentations on intermittent back order and the company is allocating supplies as they become available.

Precision Dose has all nystatin suspension presentations on intermittent back order and the company is allocating supplies as they become available.

Wockhardt USA has nystatin 100,000 units/mL suspension 60 mL and 473 mL bottles on intermittent back order and the company is allocating supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=500 Morphine Injection

May 15, 2019


Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10 mg/mL 1 mL syringes in early-2018.

Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.



Pfizer has a shortage of several prefilled syringe products, including morphine, starting in late-July 2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is prioritizing production of certain morphine Carpuject syringes.


Piramal Critical Care has Mitigo 10 mg/mL 20 mL and 25 mg/mL 20 mL vials available. Estimated Resupply Dates

Fresenius Kabi has morphine 4 mg/mL 1 mL syringes and 5 mg/mL 1 mL syringes on back order and the company estimates a release date of 2nd quarter 2019. The 2 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-May 2019. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-May 2019. The 8 mg/mL 1 mL vials are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has morphine 2 mg/mL 1 mL Carpuject syringes available in limited supply. The 0.5 mg/mL 10 mL preservative-free vials are on back order and the company estimates a release date of June 2019. The 1 mg/mL 10 mL preservative-free vials are on back order and the company estimates a release date of August 2019. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of September 2019. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of June 2019. The 8 mg/mL 1 mL Carpuject syringes and 10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of February 2020. The 25 mg/mL 1 mL preservative-free vials are on back order and the company estimates a release date of June 2019. The 50 mg/mL 20 mL vials are on back order and the company estimates a release date of May 2019. The 50 mg/mL 50 mL vials are on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Mepivacaine Injection

May 15, 2019



Pfizer states the reason for the shortage is manufacturing delays. Estimated Resupply Dates

Fresenius Kabi has 1.5% Polocaine 30 mL preservative-free vials on back order and the company estimates a release date of late-May 2019.

Pfizer has 2% Carbocaine 20 mL preservative-free vials, 2% Carbocaine 50 mL multiple-dose vials, 1% Carbocaine 30 mL preservative-free vials, 1% Carbocaine 50 mL multiple-dose vials, and 1.5% Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of March 2020.




Mannitol Injection

May 15, 2019


American Regent is not currently marketing mannitol.

Baxter did not provide a reason for the mannitol shortage.

BBraun has mannitol 500 mL premixed bags available. The 250 mL premixed bags were discontinued.

Fresenius Kabi had mannitol on shortage due to increased demand.

Pfizer has mannitol on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has mannitol 250 mg/mL 50 mL vials on back order and the company estimates a release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=341 Iopamidol Injection

May 15, 2019


Bracco Diagnostics is the sole supplier of iopamidol and did not provide a reason for the shortage.


Bracco Diagnostics has Isovue-200 (iopamidol 41%) in 50 mL vials on back order and the company cannot estimate a release date. Isovue-300 (iopamidol 61%) in 150 mL bottles are on back order and the company estimates a release date in mid-July 2019. Isovue-300 (iopamidol 61%) in 75 mL, 500 mL, 200 mL imaging bulk package, and 500 mL imaging bulk package bottles are on back order and the company cannot estimate a release date. Isovue-370 (iopamidol 76%) in 75 mL bottles are on back order and the company estimates a release date in late-June 2019. Isovue 370 (iopamidol 76%) in 150 mL, 200 mL, and 500 mL bottles are on back order and the company cannot estimate a release date.


Hydroxyprogesterone Caproate Injection

May 15, 2019


AMAG has Makena vials on shortage due to manufacturing delay.

American Regent has hydroxyprogesterone injection available.

Mylan has hydroxyprogesterone injection available.

Prasco has hydroxyprogesterone injection available.

Slayback Pharma launched hydroxyprogesterone injection in early 2019. Estimated Resupply Dates



AMAG has Makena 250 mg/mL 1 mL and 5 mL vials on back order and the company estimates a release date in 2019.


Ethiodized Oil

May 15, 2019


Guerbet has Lipiodol injection available.

Guerbet has transferred the manufacturing of Lipiodol injection to the US. As of March 2019, Lipiodol Ultra-Fluide is no longer being imported.

Guerbet had Lipiodol injection in short supply due to manufacturing problems at Jubilant HollisterStier, the manufacturing site in Canada that supplies Lipiodol for Guerbet.


None listed https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=39

Clonidine Hydrochloride Injection

May 15, 2019


American Regent and Fresenius Kabi are not currently marketing clonidine injection.



X-Gen did not provide a reason for the shortage. Estimated Resupply Dates

Hikma has clonidine 0.1 mg/mL 10 mL vials on back order and the company estimates a release date of late-May to early-June 2019. The 0.5 mg/mL 10 mL vials are on back order and the company cannot estimate a release date.

X-Gen has clonidine 0.5 mg/mL 10 mL vials on back order and the company estimates a release date of late-May 2019.

Mylan Institutional has Duraclon 0.1 mg/mL 10 mL vials on back order and the company estimates a release date of late-May 2019.


Calcium Chloride Injection

May 15, 2019


American Regent did not provide a reason for the shortage.

Amphastar has calcium chloride on shortage due to increased demand.

Pfizer has calcium chloride on shortage due to manufacturing delays.



Mylan Institutional has withdrawn calcium chloride syringes from the market. The company recalled the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors.


American Regent has calcium chloride 100 mg/mL 10 mL vials on back order and the company cannot estimate a release date.

Amphastar has calcium chloride 100 mg/mL 10 mL syringes available in limited supply.

Pfizer has calcium chloride 100 mg/mL 10 mL Ansyr syringes and 100 mg/mL 10 mL LifeShield syringes on back order and the company estimates a release date of August 2019.


Busulfan Injection

May 15, 2019



Amneal did not provide a reason for the shortage.

Athenex launched busulfan injection in March 2019.

Sagent has busulfan on shortage due to manufacturing delays. Estimated Resupply Dates

American Regent has busulfan 6 mg/mL 10 mL vials available in limited supply.

Mylan has busulfan 6 mg/mL 10 mL vials on back order and the company estimates a release date of late-May 2019.

Sagent has busulfan 6 mg/mL 10 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=509

Buspirone Tablets

May 15, 2019


Accord did not provide a reason for the shortage.


Par has buspirone tablets available.


Accord has all buspirone presentations on back order and the company cannot estimate a release date.

Mylan Institutional has buspirone 5 mg, 10 mg, 15 mg, and 30 mg tablets in 100 count unit-dose packs on back order and the company estimate a release date in mid-July 2019.

Mylan has buspirone 10 mg and 15 mg tablets in 500 count bottles on back order and the company estimates a release date in mid-June 2019.

Teva has buspirone 5 mg tablets in 500 count bottles, 10 mg tablets in 100 and 500 count bottles, and 30 mg tablets in 60 and 500 count bottles on back order and the company



estimates release dates in early-June 2019. The 15 mg tablets in 100 and 500 count bottles are on back order with an estimated release date in mid-June 2019.

Zydus has all buspirone presentations on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=465

Proparacaine Hydrochloride Ophthalmic Solution

May 16, 2019


Akorn, Bausch Health, and Sandoz did not provide a reason for the shortage. Estimated Resupply Dates

Akorn has proparacaine ophthalmic solution 0.5% available.

Bausch Health has proparacaine ophthalmic solution 0.5% available.

Sandoz has proparacaine ophthalmic solution 0.5% available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=489

Nelfinavir Mesylate Tablets

May 16, 2019


Viiv Healthcare states the shortage is due to a manufacturing issue.

Viiv Healthcare is the sole supplier of nelfinavir. Estimated Resupply Dates

Viiv Healthcare has Viracept 250 mg tablets on back order and the company estimates a release date of late-May 2019.


Isocarboxazid Tablets

May 16, 2019


Validus has Marplan tablets on shortage due to manufacturing delays Estimated Resupply Dates

Validus has Marplan on long-term back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=411



Diazepam Injection

May 16, 2019


Pfizer has diazepam on shortage due manufacturing delays.

DASH Pharmaceuticals launched diazepam injection in early-April 2019. Estimated Resupply Dates

Pfizer has diazepam 5 mg/mL 2 mL Carpuject syringes available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=330

Carisoprodol Tablets

May 16, 2019


Cadista discontinued carisoprodol tablets.

Endo Pharmaceuticals discontinued carisoprodol tablets.

Mylan discontinued generic carisoprodol tablets.

Rising discontinued carisoprodol tablets. Estimated Resupply Dates

Teva has all presentations on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=558

Bisacodyl Suppositories

May 16, 2019


Major has bisacodyl suppositories on shortage due to increased demand.

Perrigo has bisacodyl suppositories on shortage due to increased demand.

Rugby Laboratories has bisacodyl suppositories on shortage due to increased demand. Estimated Resupply Dates

Major has all bisacodyl suppositories on back order and the company cannot estimate a release date.

Perrigo has all bisacodyl suppositories on back order. The company estimates a release date of late-May 2019 for the 50 count presentation and early-June 2019 for the 12 count presentation.

Rugby Laboratories has all bisacodyl suppositories on back order and the company cannot estimate a release date.




Argatroban Injection

May 16, 2019


AuroMedics did not provide a reason for the shortage.

Chiesi has argatroban temporarily unavailable. They are in the process of transferring the product to another company.




Par has argatroban available.

Pfizer had argatroban on shortage due to manufacturing delay.

Sandoz discontinued argatroban 1 mg/mL 50 mL vials in April 2019.

Teva has argatroban temporarily unavailable. Estimated Resupply Dates

AuroMedics has argatroban 1 mg/mL 50 mL vials on intermittent back order.

Fresenius Kabi has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a release date in early-June 2019.

Hikma has argatroban 1 mg/mL 50 mL vials and 100 mg/mL 2.5 mL vials on allocation.

Mylan has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a release date in late-September 2019.


Ropivacaine Injection

May 18, 2019


Akorn has ropivacaine on shortage due to increased demand.


Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays.

Pfizer had ropivacaine on shortage due to manufacturing delays. Estimated Resupply Dates

Akorn has ropivacaine 5 mg/mL 30 mL vials on back order and the company cannot estimate a release date.

AuroMedics has ropivacaine 7.5 mg/mL 20 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has Naropin 5 mg/mL 30 mL Steripak ampules on back order and the company estimates a release date of early-July 2019. The 5 mg/mL 100 mL bottles are on back order and the company estimates a release date of late-May 2019. The 2 mg/mL 10 mL Steripak ampules are on back order and the company estimates a release date of late-June 2019. Check wholesalers for inventory.

Pfizer has ropivacaine 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of September 2019. The 5 mg/mL 30 mL vials are on back order and the company



estimates a release date of August 2019. The 7.5 mg/mL 20 mL vials are on back order and the company estimates a release date of October 2019. The 10 mg/mL 10 mL and 20 mL vials are on back order and the company estimates a release date of September 2019.


Metoprolol Injection

May 18, 2019


Alvogen has metoprolol injection available.

American Regent is not currently marketing metoprolol injection.

Athenex has metoprolol injection available.

Baxter did not provide a reason for the shortage.

Fresenius Kabi had metoprolol injection on shortage due to increased demand.

Mylan Institutional acquired metoprolol injection from Sagent. They discontinued metoprolol injection in March 2018.

Pfizer has metoprolol injection on shortage due to manufacturing delays.

Hikma did not provide a reason for the shortage. Estimated Resupply Dates

Baxter (formerly Claris) has metoprolol 1 mg/mL 5 mL vials on back order and the company estimates a release date of April 2019.

Hikma has metoprolol 1 mg/mL 10 mL vials on back order and the company estimates a release date of June to July 2019. The 5 mL vials are on back order and the company cannot estimate a release date.

Pfizer has metoprolol 1 mg/mL 5 mL Carpuject syringes on back order and the company estimates a release date of August 2020. The 1 mg/mL 5 mL ampules are on back order and the company estimates a release date of August 2020. The 1 mg/mL 5 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=363 Meperidine Hydrochloride Injection May 18, 2019 Reason for the Shortage

Pfizer has Demerol injection on shortage due to manufacturing delays.

ICU Medical discontinued meperidine 30 mL PCA vials. Estimated Resupply Dates

Hikma has meperidine 50 mg/mL 1 mL vials and 100 mg/mL 1 mL vials on back order and the company estimates a release date of June to July 2019.

Pfizer has Demerol 100 mg/mL 20 mL vials and on back order and the company estimates a release date of March 2020. The 25 mg/mL 1 mL Carpuject syringes, 50 mg/mL 1 mL Carpuject syringes, and 100 mg/mL 1 mL syringes are on back order and the company estimates a release date of October 2019. The 75 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of September 2019. The 50 mg/mL 30 mL vials are on back



order and the company estimates a release date of July 2019. The 50 mg/mL 1 mL ampules are on back order and the company estimates a release date of December 2019. The 100 mg/mL 1 mL ampules are available in limited supply.


Lidocaine with Epinephrine Injection

May 18, 2019


Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product and manufacturing delays.

Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays. Estimated Resupply Dates

Fresenius Kabi has 1% Xylocaine with epinephrine (1:200,000) 10 mL vials on back order and the company estimates release dates of early-June 2019. The 1% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates release dates of late-May 2019. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates release dates of early-June 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of late-May 2019. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates a release date of early-June 2019. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has 0.5% lidocaine with epinephrine (1:200,000) 50 mL vials available in limited supply. The 1% lidocaine with epinephrine (1:100,000) 20 mL vials are on back order and the company estimates a release date of May 2019. The 1% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of May 2019. The 1% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of June 2019. The 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates a release date of July 2019. The 1.5% lidocaine with epinephrine (1:200,000) 5 mL glass ampules are on back order and the company estimates a release date of July 2019. The 2% lidocaine with epinephrine (1:100,000) 20 mL vials are on back order and the company estimates a release date of June 2019. The 2% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of July 2019. The 2% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of June 2019.The 2% lidocaine with epinephrine (1:200,000) 20 mL vials are on intermittent back order and the company is releasing product as it becomes available.




Doxorubicin Injection

May 18, 2019


Hikma did not provide a reason for the shortage of Adriamycin.

Teva had doxorubicin solution for injection on shortage due to increased demand. They discontinued doxorubicin presentations with NDCs starting in 00703 in early-January 2019.


Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials.

Pfizer has doxorubicin on shortage due to manufacturing delays.

Sagent has doxorubicin available.

Mylan Institutional discontinued doxorubicin 10 mg lyophilized powder for injection in early 2019.

Athenex has doxorubicin available.

FDA was allowing temporary importation of doxorubicin lyophilized powder for injection 50 mg vials. These vials were manufactured for Hospira UK Limited. The labeling as well as bar coding for the imported product is different from the US version. FDA has the Dear Healthcare Professional Letter linked on their website. The letter includes a link to both the US and United Kingdom package inserts to help explain the differences in labeling and packaging. The link to the letter is http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM507498.pdf. Ordering can be done directly with Hospira Customer Care at 877-946-7747.


•Hikma has Adriamycin 10 mg vials on back order and the company estimates a release date of June 2019.


Dexamethasone Sodium Phosphate Injection

May 18, 2019


American Regent is not marketing dexamethasone sodium phosphate injection at this time.

AuroMedics has dexamethasone sodium phosphate on intermittent back order.

Fresenius Kabi has dexamethasone sodium phosphate presentations available.

Mylan Institutional has dexamethasone sodium phosphate available.


AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL, 5mL, and 30 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has dexamethasone sodium phosphate 4 mg/mL 1 mL prefilled syringes on back order and the company estimates a release date of late-May 2019. The 10 mg/mL 1 mL preservative-free vials are on back order and the company estimates a release date of late-May 2019. The 4 mg/mL 1 mL, 5 mL, and 30 mL vials are on back order and the company estimates a release date of late-May 2019 for the 1 mL and 5 mL vials and mid-June 2019 for the 30 mL vials.



The 10 mg/mL 10 mL vials are on back order and the company estimates a release date of early-June 2019.

Hikma has dexamethasone sodium phosphate 4 mg/mL 1 mL vials, 4 mg/mL 5 mL vials, and 10 mg/mL 1 mL vials on allocation.

Mylan Institutional has dexamethasone 40 mg/mL 5 mL and 30 mL vial on back order and the company estimates a release date of mid- to late-June 2019.


Bupivacaine with Epinephrine Injection

May 18, 2019


Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and manufacturing delays.

Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays. Estimated Resupply Dates

Fresenius Kabi has 0.25% Sensorcaine with epinephrine 50 mL vials on back order and the company estimates a release date of late-May 2019. The 0.25% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of early-June 2019. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of late-May 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-May 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date.

Pfizer has 0.25% bupivacaine with epinephrine 30 mL preservative-free vials on back order and the company estimates a release date of December 2019. The 0.25% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of November 2019. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of February 2020. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of May 2019.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of December 2019.

Pfizer has 0.25% Marcaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of September 2019. The 0.25% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of July 2019. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of August 2019. The 0.5% Marcaine with epinephrine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of September 2019.




Bupivacaine Injection

May 18, 2019


AuroMedics has not provided a reason for the shortage.

Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product.

Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5% bupivacaine 30 mL glass ampules in December 2017.


AuroMedics has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on intermittent back order and the company is releasing product as it becomes available. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has 0.25% Sensorcaine 30 mL preservative-free vials on back order and the company estimates a release date of late-May 2019. The 0.25% 50 mL vials are on back order and the company estimates a release date of late-May 2019. The 0.5% 10 mL preservative-free vials are on back order and the company estimates a release date of late-May 2019. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of late-May 2019. The 0.25% and 0.5% Sensorcaine 30 mL preservative-free vials in sterile packs are on back order and the company cannot estimate release dates.

Pfizer has 0.25% bupivacaine 10 mL preservative-free vials on back order and the company estimates a release date of August 2019. The 0.25% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2019. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates release dates of August 2019. The 0.5% bupivacaine 10 mL preservative-free vials are on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of June 2019. The 0.75% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of August 2019.

Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of September 2019 for the 10 mL vials and July 2019 for the 30 mL vials. The 0.25% 50 mL vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of October 2019 for the 10 mL vials and January 2020 for the 30 mL vials. The 0.5% 50 mL vials are on back order and the company estimates a release date of June 2019. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020.




Atropine Sulfate Injection

May 18, 2019


American Regent had atropine injection on shortage due to market demand.

Amphastar has atropine injection on shortage due to increased demand.

Fresenius Kabi has atropine injection available.

Hikma has atropine injection available.

Pfizer has atropine injection on shortage due to manufacturing delays. Estimated Resupply Dates

Amphastar has atropine 0.1 mg/mL 10 mL syringes available in limited supply.

Pfizer has atropine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company estimates release dates of August 2019. The 0.1 mg/mL 10 mL Ansyr syringes are on back order and the company estimates a release date of August 2019. The 0.1 mg/mL 5 mL LifeShield syringes are on back order and the company estimates release dates of August 2019. The 0.05 mg/mL 5 mL Ansyr syringes are available with an expiration date of August 2019.


Valganciclovir HCl Oral Powder for Solution

May 20, 2019



Teva has valganciclovir 50 mg/mL 100 mL bottles on back order and the company estimates a release date of late-May 2019.


Testosterone Enanthate Intramuscular Injection

May 20, 2019


Hikma has testosterone enanthate available.


Teva has testosterone enanthate 200 mg/mL 5 mL vials temporarily unavailable with no

estimated release date.




Phenytoin Sodium Injection

May 20, 2019


Hikma did not provide a reason for this shortage.

X-Gen Pharmaceuticals discontinued their phenytoin sodium presentations in April 2017. Estimated Resupply Dates

Hikma has phenytoin sodium 50 mg/mL 2 mL and 5 mL vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=406

Methyldopa Tablets

May 20, 2019


Accord has methyldopa tablets available.


Teva discontinued methyldopa tablets in 2018. Estimated Resupply Dates

Mylan has methyldopa 250 mg tablets and 500 mg tablets in 100 count bottles on back order and the company estimates a release date of early-January 2020. The 250 mg tablets and 500 mg tablets in 100 count unit-dose packs are on back order and the company estimates a release date of mid-January 2020.


Leucovorin Calcium Injection

May 20, 2019


Fresenius Kabi had leucovorin on shortage due to manufacturing delays and increased demand.

Hikma did not provide a reason for the current shortage.

Mylan Institutional has leucovorin available.

Sagent has leucovorin on shortage due to manufacturing delays.

Teva has leucovorin available. Estimated Resupply Dates

Fresenius Kabi has leucovorin 200 mg vials on back order and the company estimates a release date of late-May 2019.

Hikma has leucovorin 200 mg and 350 mg vials on back order and the company estimates a release date of June to July 2019.

Sagent has leucovorin 50 mg, 100 mg, 200 mg, 350 mg, and 500 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35



Enalaprilat Injection

May 20, 2019


Hikma has enalaprilat injection on shortage due to increased demand.

Pfizer has enalaprilat injection on shortage due to manufacturing delays Estimated Resupply Dates

Hikma has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials on allocation.

Pfizer has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials on back order and the company estimates a release date of March 2020.


Dicyclomine Injection

May 20, 2019


Allergan has Bentyl injection available.



Nexus has dicyclomine injection for intramuscular use available. Estimated Resupply Dates

Hikma has dicyclomine 10 mg/mL 2 mL vials on back order and the company cannot estimate a release date.


Acetylcysteine Oral and Inhalation Solution

May 20, 2019


American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

Arbor discontinued Cetylev effervescent tablets in April 2019.

Fresenius Kabi has acetylcysteine oral and inhalation solution available.

Pfizer had acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014. Estimated Resupply Dates

American Regent has acetylcysteine solution 100 mg/mL 4 mL vials available in limited supply. The 200 mg/mL 4 mL and 30 mL vials are on back order and the company cannot estimate a release date.

Fresenius Kabi has short-dated acetylcysteine 100 mg/mL 4 mL and 30 mL vials available with an expiration date of <5 months.




23.4% Sodium Chloride Injection

May 20, 2019


Fresenius Kabi has 23.4% sodium chloride injection on shortage due to increased demand.

Pfizer has 23.4% sodium chloride injection on shortage due to increased demand. Estimated Resupply Dates

Fresenius Kabi has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release date of early-June 2019. The 100 mL vials are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release date of December 2019.


Olanzapine Intramuscular Injection

May 21, 2019



Lilly has Zyprexa intramuscular injection available.

Sandoz did not provide a reason for the shortage. Estimated Resupply Dates

American Regent has olanzapine 10 mg vials for intramuscular injection available in limited supply.


Ketorolac Injection

May 21, 2019


Alvogen did not provide a reason for the shortage.

Amphastar did not provide a reason for the shortage.

Athenex has ketorolac available

BD RX is now part of Fresenius Kabi.

Fresenius Kabi has most ketorolac presentations available.

Pfizer has ketorolac injection on back order due to manufacturing delays.

Sagent states the reason for the shortage is manufacturing delay.


Ben Venue closed its plant in Bedford, Ohio in July 2014.

Virtus discontinued ketorolac in March 2019.

FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac.



Sprix Nasal Spray is not affected by this shortage. Estimated Resupply Dates

Alvogen has ketorolac 30 mg/mL 1 mL vials on allocation. The 30 mg/mL 2 mL vials are on back order and the company estimates a release date of late-May 2019.

Amphastar has ketorolac 30 mg/mL 1 mL vials on back order and the company cannot estimate a release date.

Fresenius Kabi has ketorolac 15 mg/mL 1 mL prefilled syringes on back order and the company estimates a release date of 3rd quarter 2019. The 30 mg/mL 2 mL syringes for intramuscular use are on back order and the company estimates a release date of 3rd quarter 2019. Product is available with short expiration dating for ketorolac 15 mg/mL 1 mL prefilled syringes (< 1 month) and 30 mg/mL 2 mL prefilled syringes for intramuscular use (< 2 months). The 30 mg/mL 1 mL vials are on back order and the company estimates a release date of late-May 2019. There are short-dated 30 mg/mL 1 mL syringes available with an expiration date of <9 months.

Hikma has all ketorolac presentations on back order. The company estimates a release date of June 2019 for the ketorolac 15 mg/mL 1 mL vials. The company estimates a release date of June to July 2019 for the 30 mg/mL 1 mL and 2 mL vials.

Pfizer has ketorolac 30 mg/mL 1 mL Carpuject syringes, 30 mg/mL 2 mL Carpuject syringes for intramuscular injection, and 30 mg/mL 1 mL iSecure syringes on back order and the company estimates a release date of September 2019. The ketorolac 30 mg/mL 1 mL vials are on back order and the company estimates a release date of August 2019.

Sagent has ketorolac 15 mg/mL 1 mL vials, 30 mg/mL 1 mL vials, and 30 mg/mL 2 mL vials for intramuscular injection are on back order and the company estimates a release date of August 2019.


Hydralazine injection

May 21, 2019


Akorn has product on back order due to increased demand.

American Regent is not currently marketing hydralazine injection.


X-Gen did not provide a reason for the shortage. Estimated Resupply Dates

Akorn has hydralazine 20 mg/mL 1 mL vials on back order and the company cannot estimate a release date.

X-Gen has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a release date of late-June 2019.




Erythromycin Ophthalmic Ointment

May 21, 2019



Bausch Health did not provide a reason for the shortage.

Perrigo has erythromycin ophthalmic ointment on shortage due to increased demand. Estimated Resupply Dates

Akorn has erythromycin 0.5% ophthalmic ointment in 3.5 gram tubes on back order and the company is allocating product when it becomes available. The 1 gram tubes are on allocation.

Bausch Health has erythromycin 0.5% ophthalmic ointment in 1 gram and 3.5 gram tubes on back order and the company estimates a release date of mid-June 2019.

Perrigo has erythromycin 0.5% ophthalmic ointment in 1 gram tubes and 3.5 gram tubes in single count on allocation. The 3.5 gram tubes in 24 count are on back order and the company cannot estimate a release date.


Ceftriaxone Sodium Injection

May 21, 2019


Apotex has ceftriaxone available.

Fresenius Kabi states the reason for the shortage was increased demand.

Pfizer had ceftriaxone injection on shortage due to increased demand and manufacturing delays.

Sagent states the reason for the shortage is manufacturing delay.


Hikma states the reason for the shortage is manufacturing delay.

Wockhardt has discontinued their ceftriaxone presentations. Estimated Resupply Dates

Lupin has all ceftriaxone presentations on back order and the company cannot estimate a release date.

Hikma has ceftriaxone 250 mg and 500 mg vials on back order and the company cannot estimate a release date.

Sagent has ceftriaxone 500 mg vials on back order and the company estimates a release date in May 2019.




Calcitriol Injection

May 21, 2019


Akorn did not provide a reason for the shortage. Estimated Resupply Dates

Akorn has calcitriol 1 mcg/mL 1 mL ampules available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=464

Benztropine Mesylate Injection

May 21, 2019





Akorn has benztropine 1 mg/mL 2 mL ampules and Cogentin 1 mg/mL 2 mL ampules on back order and the company cannot estimate a release date.


Amino Acid Products

May 21, 2019


Baxter has most presentations available. Baxter discontinued Premasol in late-2018.

BBraun did not provide a reason for the shortage.

ICU Medical has Aminosyn presentations available. ICU Medical discontinued several Aminosyn products in September 2018.


BBraun has Trophamine 10% 500 mL and Plenamine 15% 1,000 mL glass containers on intermittent back order and the company is releasing supplies as they become available.

Baxter has Premasol 10% 500 mL and 10% 2,000 mL flexible containers in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=564



Albuterol Inhalation Solution

May 21, 2019


Akorn did not provide a reason for the shortage. Estimated Resupply Dates

All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=470

Valsartan Tablets

May 22, 2019


Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probable human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

Camber, Major, Solco, and Teva valsartan tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

Major, Solco, and Teva discontinued valsartan tablets in July 2018.

Alembic, Aurobindo, Cadista, Mylan, Macleods, and Novartis are not affected by this recall.

Aurobindo refused to provide updated availability information.

Lupin is not actively marketing valsartan tablets.

Repackagers may have some presentations affected depending on the source supplier. Estimated Resupply Dates

Alembic has all 500 count presentations on back order and the company cannot estimate a release date.

Camber has valsartan tablets on back order and the company cannot estimate a release date.

Mylan has valsartan tablets on intermittent back order and the company is releasing supplies as they become available.


Temazepam Capsules

May 22, 2019


Ascend did not provide a reason for the shortage.

Major has temazepam on shortage due to manufacturing delays.

Mylan has temazepam on shortage due to manufacturing delays.

Sun Pharma has temazepam available.

Teva did not provide a reason for the shortage.



Mallinckrodt has Restoril capsules available. Estimated Resupply Dates

Ascend has temazepam 15 mg capsules in 100 count on allocation. The 7.5 mg capsules in 100 count and 30 mg capsules in 500 count are on back order and the company cannot estimate a release date.

Major has temazepam 7.5 mg capsules in 100 count bottles on back order and the company cannot estimate a release date.

Mylan has temazepam 15 mg capsules in 100 and 500 count, 22.5 mg capsules in 30 count, and 30 mg capsules in 100 and 500 count on back order and the company estimates a release date of August 2019.

Mylan Institutional has temazepam 30 mg capsules in 100 count unit-dose packs on back order and the company estimates a release date of early-September 2019.

Teva has all temazepam capsule presentations on back order and the company estimates a release date of late-May 2019.


Spironolactone Tablets

May 22, 2019


Amneal, Mylan, and Sun Pharma did not provide a reason for the shortage.

Accord and Cadista has spironolactone tablets available.

Par discontinued spironolactone tablets in August 2018.

Pfizer has Aldactone available. Estimated Resupply Dates

Cadista has all presentations on allocation.

Mylan has spironolactone 50 mg tablets in 100 and 500 count bottles and 25 mg tablets in 100 count bottles on back order and the company estimates a release date of mid-June 2019 for the 25 mg and 50 mg tablets in 100 count bottles and late-May 2019 for the 50 mg tablets in 500 count bottles. The 50 mg tablets in 100 count unit-dose packs are on back order and the company estimates a release date of early-June 2019. The 100 mg tablets in 100 count unit-dose packs are on back order and the company cannot estimate a release date.

Sun Pharma has spironolactone 25 mg tablets in 100 and 1000 count, 50 mg tablets in 60 and 500 count, and 100 mg in 100 count on back order and the company cannot estimate a release date.


Sodium Polystyrene Sulfonate Oral or Rectal Suspension

May 22, 2019


CMP Pharma reports that increased demand has led to a shortage of raw material required to manufacture the products. They are using available powder to manufacture the suspension.



Perrigo has temporarily discontinued their Kionex suspension and sodium polystyrene sulfonate (sorbitol-free) suspension. They cannot estimate when these products will be manufactured again.

Hikma is not currently marketing sodium polystyrene sulfonate suspension. Estimated Resupply Dates

CMP Pharma has SPS Suspension on intermittent back order and the company is shipping supplies as they become available.


Rosuvastatin Calcium Tablets

May 22, 2019


Accord, Biocon, and Rising did not provide a reason for the shortage.

Apotex has discontinued production of all rosuvastatin presentations.

Aurobindo refuses to provide updated availability information.

Camber, Glenmark, and Sandoz have rosuvastatin presentations available.

Mylan has discontinued all rosuvastatin presentations.

Sun Pharma will be discontinuing production of all rosuvastatin presentations. Estimated Resupply Dates

Accord has rosuvastatin 40 mg tablets in 1000 count bottles on intermittent back order and the company is releasing supplies as they become available.

Biocon has most rosuvastatin presentations on intermittent back order and the company is releasing supplies as they become available.

Rising has all rosuvastatin presentations on allocation.

Sun Pharma will be discontinuing production of rosuvastatin 5 mg, 10 mg, 20 mg, and 40 mg tablets in 90 count bottles.


Metronidazole Hydrochloride Injection

May 22, 2019


Pfizer has metronidazole injection on shortage due to manufacturing delay.

BBraun has metronidazole injection available. Estimated Resupply Dates

Baxter has metronidazole 100 mL bags (NDC 36000-0001-24) on back order and the company cannot estimate a release date.

Pfizer has metronidazole 100 mL bags in 24 count available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=316



Hypromellose Ophthalmic Solution

May 22, 2019


Akorn has hypromellose ophthalmic solution on shortage due to lack of raw materials.

HUB Pharmaceuticals has hypromellose ophthalmic solution on long-term back order and did not provide a reason.

Altaire has Goniotaire available.

OcuSoft has Goniosoft available. Estimated Resupply Dates

Akorn has Gonak 2.5% ophthalmic solution 15 mL bottles on allocation.

HUB Pharmaceuticals has Goniovisc 2.5% ophthalmic solution 15 mL bottles on long-term back order and the company cannot estimate a release date.


Hepatitis B Vaccine (Recombinant)

May 22, 2019


Merck has Recombivax HB on shortage due to increase in global demand.

GlaxoSmithKline has Engerix B products available.

GlaxoSmithKline discontinued Engerix B pediatric vials in October 2017. Estimated Resupply Dates

Merck has Recombivax HB adult formulation vials and syringes on back order and the company estimates this will continue through 2019.

Merck has Recombivax HB pediatric/adolescent formulation syringes and pediatric/adolescent formulation vials in limited supply and this will continue through 2019. Merck's limited supply is being allocated to the CDC to ensure use is in accordance with their clinical guidance.

Merck has Recombivax HB dialysis formulation 40 mcg/mL on back order and the company estimates this will continue through 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=320 Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection

May 22, 2019


Accord has dexmedetomidine vials available.

Akorn has dexmedetomidine vials available.

Athenex has dexmedetomidine vials available.

AuroMedics has dexmedetomidine vials available.

Fresenius Kabi has dexmedetomidine vials available.

Hikma has dexmedetomidine vials available.




Par has dexmedetomidine vials available.

Pfizer has dexmedetomidine vials available.

Sandoz has dexmedetomidine vials available.

Sun Pharma is no longer manufacturing dexmedetomidine.

Teva did not provide a reason for the temporary discontinuation of dexmedetomidine vials.

WG Critical Care has dexmedetomidine vials on back order due to manufacturing delays. Estimated Resupply Dates

Teva has temporarily discontinued dexmedetomidine 100 mcg/mL 2 mL vials and the company cannot estimate a resupply date.

WG Critical Care has dexmedetomidine 100 mcg/mL 4 mL and 10 mL vials on intermittent back order and the company is releasing supplies as they become available.


Azithromycin Injection

May 22, 2019


Apotex has discontinued azithromycin injection.


Fresenius Kabi has azithromycin injection on shortage due to increased demand.

Pfizer has azithromycin injection on shortage due to manufacturing delays.

Sun Pharma is not currently manufacturing azithromycin injection. Estimated Resupply Dates

AuroMedics has azithromycin 500 mg vials on intermittent back order and the company is releasing product as it becomes available.

Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a release date of March 2020. Zithromax 500 mg vials are on back order and the company estimates a release date of October 2019.


Asparaginase Erwinia chrysanthemi

May 22, 2019


Jazz Pharmaceuticals did not provide a reason for the shortage. Estimated Resupply Dates

Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count on back order and the company estimates a release date in early-June 2019. There is a new process for ordering Erwinaze. Additional information regarding the new ordering process is available at www.erwinazesupply.com.




5% Dextrose Injection (PVC-free and DEHP-free)

May 22, 2019


Baxter is not currently marketing 5% dextrose PVC/DEHP-free bags.

BBraun had 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays.

BD has 5% dextrose PVC/DEHP-free bags available.

Fresenius Kabi has 5% dextrose PVC/DEHP-free bags available.

ICU Medical has 5% dextrose PVC/DEHP-free bags due to manufacturing delays. Estimated Resupply Dates

ICU Medical has 5% dextrose PVC/DEHP-free 50 mL VisIV bags on back order and the company estimates a release date in early-July 2019. The 250 mL VisIV bags are available to contracted customers only.


*Please refer to ASHP website for more information at: https://www.ashp.org/Drug-Shortages/Current-Shortages

https://www.ashp.org/Drug-Shortages/Current-Shortages

https://www.ashp.org/Drug-Shortages/Current-Shortages

Documents

Drug Information Update · 2019-05-29 · NEW INDICATIONS (EXISTING DRUGS) BENLYSTA® April 26, 2019 GSK announced today that the US Food and Drug Administration (FDA) has approved,