drug information update · 2018-05-29 · novartis today announced the us food and drug...

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Drug Information Update May 2018

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TABLE OF CONTENTS NEWLY AVAILABLE GENERICS ................................................................................ 2 NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS .............................................. 3 NEW INDICATIONS (EXISTING DRUGS) ................................................................... 5 FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ............................................. 7 STUDIES AND RECENT TOPICS ................................................................................ 9 RECALLS ............................................................................................................... 13

CURRENT DRUG SHORTAGES ............................................................................... 43


NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE FORM

GENERIC MANUFACTURER BRAND NAME

DOXYCYCLINE HYCLATE 50 mg TABLET JOURNEY MEDICAL TARGADOX

PRAZIQUANTEL 600 mg TABLET PAR PHARM. BILTRICIDE

PHENOBARB/HYOSCY/ATROPINE/SCOP 16.2 mg-0.1037 mg-0.0194 mg-0.0065 mg/5 mL ELIXIR

MAJOR PHARM. DONNATAL

CYPROHEPTADINE HCL 4 mg/10 mL SYRUP PHARMACEUTICAL CYPROHEPTADINE HCL


NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

FIBROBLAST GROWTH FACTOR 23 (FGF23) INHIBITORS

CRYSVITA BUROSUMAB-TWZA 10 MG/ML New Entity





GLUCOCORTICOIDS TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETON/0.9% NACL

50 MG/ML New Combination

GLUCOCORTICOIDS TRIAMCINOLONE DIACETATE

TRIAMCINOLONE DIA/0.9% NACL/PF



TRIAMCINOLONE DIACET/0.9% NACL



TRIAMCINOLONE DIACET/0.9% NACL


TOPICAL LOCAL ANESTHETICS LIDOTREX LIDOCAINE HCL/ALOE/COLLAGEN

2%-1%-1.2% New Combination

ARGININE VASOPRESSIN (AVP) RECEPTOR ANTAGONISTS

JYNARQUE TOLVAPTAN 90 MG-30MG New Strength





ANTIVIRALS, GENERAL GANCICLOVIR SODIUM

GANCICLOVIR SODIUM 500MG/10ML New Strength

ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR

HUMIRA ADALIMUMAB 40 mg/0.4 mL New Strength




DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES




HUMIRA PEDIATRIC CROHN'S

ADALIMUMAB 80 mg/0.8 mL New Strength


HUMIRA PEDIATRIC CROHN'S

ADALIMUMAB 80 mg/0.8 mL-40 mg/0.4 mL

New Package Size


HUMIRA PEN ADALIMUMAB 40 mg/0.4 mL New Strength

ANTINEOPLASTIC-CD19 DIR. CAR-T CELL IMMUNOTHERAPY

KYMRIAH TISAGENLECLEUCEL

0.6 x 10exp8 to 6 x 10exp8 cell

New Strength

ANTIEMETIC/ANTIVERTIGO AGENTS AKYNZEO

FOSNETUPITANT/PALONOSETRON

235 mg-0.25 mg New Entity

ANTICOAGULANT REVERSAL AGENT FOR FACTOR XA INHIB.

ANDEXXA FACTOR XA,INACTIVATED-ZHZO

100 mg New Entity

EYE ANTIBIOTIC AND GLUCOCORTICOID COMBINATIONS

DEXAMETHASONE-MOXIFLOXACIN

MOXI/DEXAMETH/NACL,ISO-OSMO/PF

5 mg-1 mg/mL New Combination

OPHTHALMIC ANTIBIOTICS MOXIFLOXACIN MOXIFLOXACIN IN NACL,ISO-OS/PF

5 mg/mL New Strength and Dosage Form

SPLEEN TYROSINE KINASE INHIBITORS TAVALISSE FOSTAMATINIB

DISODIUM 150 mg New Entity

SPLEEN TYROSINE KINASE INHIBITORS TAVALISSE FOSTAMATINIB

DISODIUM 100 mg New Entity

PANCREATIC ENZYMES ZENPEP LIPASE/PROTEASE/AMYLASE

15,000 unit-47,000 unit-63,000 unit

New Strength


NEW INDICATIONS (EXISTING DRUGS) Tafinlar® + Mekinist® April 30, 2018 Novartis announced today that the US Food and Drug Administration (FDA) has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. The FDA granted the combination Breakthrough Therapy Designation for this indication in October 2017 and Priority Review in December 2017. Source: Novartis Kymriah® May 1, 2018 Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication - the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Kymriah is not indicated for the treatment of patients with primary central nervous system lymphoma. Kymriah, developed in collaboration with the University of Pennsylvania, became the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is now the only CAR-T cell therapy to receive FDA approval for two distinct indications in non-Hodgkin lymphoma (NHL) and B-cell ALL. Source: Novartis TAGRISSO® April 18, 2018 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved TAGRISSO® (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. The approval is based on results from the Phase III FLAURA trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine. Source: AstraZeneca Truvada® May 15, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. The safety and efficacy profile of Truvada for HIV prevention in uninfected adults, a


strategy called pre-exposure prophylaxis (PrEP), is well established, and Truvada for PrEP was first approved for use in adults in 2012. Source: Gilead Sciences, Inc. Gilenya® May 11, 2018 Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for these patients. Source: Novartis Actemra® May 14, 2018 Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older. Actemra can be given alone or in combination with methotrexate (MTX) in patients with PJIA. In 2013, FDA approved the intravenous (IV) formulation of Actemra for patients two years of age and older with active PJIA. Source: Genentech BRIVIACT® May 14, 2018 UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the company’s newest anti-epileptic drug (AED) BRIVIACT® (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in the treatment of partial onset (focal) seizures in patients age four years and older. Source: UCB DARZALEX® May 7, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved DARZALEX® (daratumumab) in combination with VELCADE® (bortezomib)*, a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone - VMP - for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). DARZALEX® is the first monoclonal antibody approved for newly diagnosed patients with this disease. Clinical trial results showed DARZALEX® in combination with VMP reduced the risk of disease progression or death by 50 percent compared to treatment with VMP alone. Source: Janssen Pharmaceutical Companies


FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction [Posted 04/25/2018] ISSUE: The FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels. BACKGROUND: The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system. HLH typically presents as a persistent fever, usually greater than 101°F, and it can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs. Lamotrigine is used alone or with other medicines to treat seizures in patients two years and older. It may also be used as maintenance treatment in patients with bipolar disorder to help delay the occurrence of mood episodes such as depression, mania, or hypomania. Stopping lamotrigine without first talking to a prescriber can lead to uncontrolled seizures, or new or worsening mental health problems. Lamotrigine has been approved and on the market for 24 years, and is available under the brand name Lamictal and as generics. RECOMMENDATION: Healthcare professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality. Diagnosis is often complicated because early signs and symptoms such as fever and rash are not specific. HLH may also be confused with other serious immune-related adverse reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Source: U.S. Food and Drug Administration (FDA) Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matt [Posted 05/08/2018] ISSUE: AuroMedics Pharma is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose vials, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients. In the event the particulate is administered to the patient, it may result in local site reaction, phlebitis, pulmonary granuloma, occlusion of blood vessels, thromboembolic events and systemic immune response. Patients with vascular disease may be at particular risk of embolic events which could cause permanent impairment or damage to a body structure or function. The risk is reduced by the possibility of detection. To date, AuroMedics Pharma has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots.


BACKGROUND: Ampicillin and Sulbactam for Injection is an intravenously or intramuscularly administered antibiotic used for the treatment of infections due to susceptible strains in adults and pediatric patients one year and older. It is packaged in a carton containing 10 vials, NDC 55150-117-20. The affected Ampicillin and Sulbactam for Injection lots being recalled are AS0317041-A, Exp. Aug 2019, and AS0317035-A, Exp. Aug 2019. RECOMMENDATION: AuroMedics Pharma is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate. Source: U.S. Food and Drug Administration (FDA) Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter [Posted 05/08/2018] ISSUE: AuroMedics Pharma is voluntarily recalling two lots of Piperacillin and Tazobactam for Injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial. 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, AuroMedics Pharma has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots. BACKGROUND: Piperacillin and Tazobactam for Injection is used for treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in intra-abdominal, skin and skin structure and female pelvic infections as well as community acquired and nosocomial pneumonia. It is packaged in a carton containing 10 single-dose vials, NDC: 55150-120-30. The affected Piperacillin and Tazobactam for Injection lots being recalled are PP0317061-A, Exp. Aug 2019, and PP0317049-A, Exp. Aug 2019. RECOMMENDATION: AuroMedics Pharma is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lots which are being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate. Source: U.S. Food and Drug Administration (FDA)


STUDIES AND RECENT TOPICS New data: Americans filling far fewer opioid prescriptions April 19, 2018 The number of prescriptions for opioid painkillers filled in the U.S. fell dramatically last year, showing their biggest drop in 25 years and continuing a decline amid increasing legal restrictions and public awareness of the dangers of addiction, new data show. Source: apnews.com Good news, Glaxo: Novartis' Advair copy definitely won't see the market this year April 20, 2018 Novartis’ prospects for launching a copy of GlaxoSmithKline’s Advair this year just went from highly unlikely to not happening. That would-be generic was turned back by the FDA in February, and now the company expects to have to complete a small bioequivalence bridging study, CEO Vas Narasimhan told investors Thursday on Novartis' first-quarter conference call. Source: fiercepharma.com Hormone therapy raises diabetes risk in breast cancer survivors April 24, 2018 Hormone therapy for breast cancer more than doubles a woman’s risk for developing type 2 diabetes, results of a case-cohort study suggest. Hormone therapy with tamoxifen was associated with a more than twofold increase in risk of diabetes, and aromatase inhibitors were associated with a more than fourfold increase, reported Hatem Hamood, MD, of Leumit Health Services in Karmiel, Israel, and colleagues. Source: mdedge.com Pfizer's Trumenba just got closer to a new FDA nod. Can it catch up to GlaxoSmithKline's Bexsero? April 24, 2018 Hot on the heels of men B rival GlaxoSmithKline, Pfizer's vaccine Trumenba picked up an FDA “breakthrough” designation that could speed its move toward a bigger market. And with the Pfizer shot's sales lagging behind GSK's Bexsero, Trumenba could use the lift. Source: fiercepharma.com


FDA re-examining Parkinson's drug after reports of deaths April 25, 2018 The Food and Drug Administration (FDA) is re-examining the safety of a new drug after reports that it has potentially caused serious side effects and numerous deaths. The agency confirmed to The Hill it is “conducting an evaluation of available information” about Nuplazid, a drug approved in 2016 to treat delusions and hallucinations associated with Parkinson’s disease psychosis. Source: thehill.com What's the Best First-Line Tx for Gestational Diabetes? May 1, 2018 Study findings did not support noninferiority of an oral second-generation sulfonylurea for prevention of perinatal complications of gestational diabetes, researchers reported. Source: medpagetoday Simple Drug Packaging Change Could Save Toddlers' Lives May 3, 2018 As America's opioid crisis continues, too many toddlers are accidentally overdosing on narcotic medicines. But a new study suggests that better packaging might curb the problem. Among kids under the age of 6, single-dose packaging prompted a 79 percent decrease in the number of unintentional exposures to a narcotic called buprenorphine. The medication is given alone or with the drug naloxone to help drug abusers beat their addiction. Source: consumer.healthday.com Pill dispenser that's set by timer may stop opioid addiction before it starts May 4, 2018 It wasn’t even noon, and physician assistant Afton Heitzenrater had already taken nine phone calls from patients of the orthopedic practice who said they were out of pain medication. Around the same time, Heitzenrater said, a young, healthy cousin died from an overdose of prescription medication. Source: democratandchronicle.com


Prescribing opioids and antidote at the same time to prevent overdose deaths May 8, 2018 A growing number of states are requiring doctors to prescribe a drug overdose antidote alongside prescription opioid painkillers to try to reduce drug deaths.

Under the laws, doctors are to prescribe naloxone when they give patients a certain dose of pills for drugs such as Percocet, Vicodin, OxyContin, and Tramadol or if patients have ever overdosed before. Naloxone can come in the form of a nasal spray, known as Narcan, or an auto-injector known as Evzio.

Source: washingtonexaminer.com

Mylan Faces EpiPen Shortage as Slowing Sales Trip Up Its Results May 9, 2018 Mylan NV’s EpiPen has been hard to find in some areas because of production problems, U.S. regulators said, as the drugmaker reported that declining sales of the lifesaving allergy-shot device weighed on its results.

Source: bloomberg.com Opioid crisis spurs sometimes-deadly abuse of popular diarrhea medicine May 13, 2018 The opioid crisis has taken what the FDA calls "many new and troubling turns," and this is one of them. Opioid addicts are buying a popular diarrhea medicine, loperamide, sold under the brand name Imodium -- to get high or as a way to taper off opioids. Source: abcnews.go.com New Digital Platform is Increasing Inhaler Adherence May 15, 2018 Mount Sinai Health System has been using Wellth to reward patients for their medication adherence. Monetary rewards play well in the behavioral economics model of using digital health to change habits. Often these days, digital health has been said to be a behavioral science—though I am not too sure—but I do believe it plays a significant role. Source: pharmacytimes.com Many Drugs Could Come Equipped with Ingestible Sensors


May 16, 2018 Proteus Digital Health recently announced a new pipeline of research using their bioingestible sensors. Now, if you are not familiar with Proteus Digital Health, you may at least have heard of one of their recent products that got FDA approval. Otsuka had teamed up with Proteus several years back and will be releasing their Abilify MYCITE to the market this year. I had written about this product, but the breakdown is that patients on the Abilify MYCITE can be monitored for their adherence. Source: pharmacytimes.com FDA hits CDMO Ei for making drugs and pesticides with same equipment May 16, 2018 The FDA hit Ei, a CDMO, with a warning letter for manufacturing pharmaceuticals in the same building and with the same equipment it uses to produce pesticides.

In its letter posted to the regulatory agency’s website, the FDA outlined poor manufacturing procedures at the company’s facility located in Kannapolis, North Carolina. The plant, which produces finished pharmaceuticals like liquid and semisolid topical drugs, was inspected in early October 2017.

Source: fiercepharma.com

FDA floats end to 'confusing and inefficient' drug-device process May 16, 2018 The FDA is proposing to eliminate a mechanism for reconsidering the regulatory classification of combination products. Officials put the process on the chopping block after determining it is confusing, inefficient and unlikely to lead to the original decision being overturned.

Source: fiercebiotech.com

Could Nonprofit Drug Companies Cut Sky-High Prices? May 17, 2018 Generic prescription drugs should be cheap, but prices for some have soared in the United States in recent years. Now a group of U.S. hospitals thinks it has a solution: a nonprofit drug maker. Earlier this year, the consortium of several large hospital systems announced it would form a nonprofit drug company called Project Rx.

Source: usnews.com


RECALLS

Product Type Product Description Class Code Info Reason for Recall Recalling

Firm Drugs All Alka-Seltzer Plus¿

packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

Class I The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall

Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.

Bayer HealthCare Pharmaceuticals, Inc.

Drugs Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

Class II a) D167C, exp 2/18; b) D172C, exp 2/18, H057C, exp 6/18; c) D164C, exp 2/18, E135C, exp 3/18; d) D172C, exp 2/18, E135C, exp 3/18, F004C, exp 5/18; e) D175C, D176C, D177C, D178C, D179C, D180C, D162C, D163C, D164C, D165C, D166C, D168C, D169C, D170C, D171C, D173C, E104C, E105C, D191C, D192C, D193C, D194C, D195C, D196C, D197C, D198C, D199C, D200C, D201C, E106C, exp 2/18; L111C, F005C, F006C, F007C, F008C, H053C, H054C, H055C, H056C, exp 5/18;

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc.



Firm L112C, L113C, L114C, L115C, L116C, L117C, L118C, L119C, J008C, J009C, H057C, H058C, exp 6/18; L120C, L121C, L122C, L123C, L124C, exp 8/18

Drugs Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256

Class II a) D167C, exp 2/18, E135C, exp 3/18; b) D172C, exp 2/18; c) D167C, exp 2/18, E135C, exp 3/18



Drugs Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

Class II a) M104C, exp 9/18, L016C, H092C, and H093C, exp 9/18 b) C128C, C129C, C130C, C132C, exp 3/18, HK6011, exp 7/18, L016C and H092C, exp 9/18,



Drugs Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

Class II C128C, C129C, exp 3/18





Firm Drugs Ibuprofen Tablets USP

600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

Class II a) C135C, D044C, D045C, D038C, exp 3/18, F069C, exp 4/18, H095C, exp 9/18 b) C134C, C136C, D039C, D040C, D041C, D042C, D043C, exp 3/18, F043C F067C, F068C, D046C, D047C, exp 4/18, H094C, exp 7/18 H096C, L026C, and H095C, exp 9/18



Drugs Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

Class II a) D044C, D038C, D043C, exp 3/18, b) C136C, exp 3/18, D039C, D040C, D041C, D042C, 3/18



Drugs Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256

Class II a) C135C, exp 3/18 b) C134C, exp 3/18



Drugs Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722,

Class II a) C139C, C140C, exp 2/18, F044C, exp 8/18; b) D048C, D049C, D050C, D051C, C142C, C137C, C138C, C139C, C141C, exp 2/18; D052C, K207C, K208C, K209C, K210C, K211C,





Firm India K212C,

HM6122, HM6123, HM6124, HM6125, HM6126, K109C, K110C, K111C, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, F044C, H097C, H098C, H099C, H100C, H101C, K096C, K097C, K098C, K099C, K100C, K101C, K102C, exp 8/18; M105C, L017C, L018C, L019C, L020C, L021C, L022C, exp 9/18

Drugs Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

Class II a) C140C, exp 2/18; b) D049C, D050C, D051C, C142C, C137C, C138C, C141C, exp 2/18; D073C, D074C, exp 3/18



Drugs Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735,

Class II a) F066C b) F066C c) F066C





Firm Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

Drugs Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

Class II a) F066C b) F066C c) F066C



Drugs CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lot: C/010218 Discard by 07/01/2018; CAC/013118 Discard by 4/1/2018; CAC/020518 Discard by 4/6/2018; CAC/021418 Discard by 4/15/2018

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Coastal Meds, LLC.

Drugs ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lot: AP/011218 Discard by 7/11/2018


Coastal Meds, LLC.

Drugs HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lots: CAH/101617 Discard by 04/14/2018; H/120117 Discard by 5/30/2018; H/010518 Discard by 7/4/2018; H/020718 Discard by


Coastal Meds, LLC.



Firm 8/6/2018; H/021518 Discard by 8/14/2018 ; CAH/021218 Discard by 4/13/2018

Drugs LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lots: LB/100517 Discard by 4/3/2018; LB/111717 Discard by 5/16/2018; LB/120717 Discard by 6/5/2018; LB/010418 Discard by 7/3/2018; LB/012618 Discard by 7/25/2018; LB/022118 Discard by 8/20/2018; CALB/012918 Discard by 3/30/2018; CALB/021218 Discard by 4/13/2018


Coastal Meds, LLC.

Drugs LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lots: LD/120417 Discard by 6/2/2018; LD/122017 Discard by 6/18/2018; LD/011618 Discard by 7/15/2018; CALD/013118 Discard by 4/1/2018; CALD/020518 Discard by 4/6/2018; CALD/021418 Discard by 4/15/2018


Coastal Meds, LLC.



Firm Drugs LIPO-DEN EXTREME

Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lots: LE/101917 Discard by 4/17/2018; LE/110317 Discard by 5/2/2018; LE/110917 Discard by 5/8/2018; LE/010318 Discard by 7/2/2018; LE/012218 Discard by 7/21/2018; LE/020918 Discard by 8/8/2017


Coastal Meds, LLC.

Drugs LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lots: LDP/100317 Discard by 4/1/2018; LDP/011618 Discard by 7/15/2018; CALDP/020118 Discard by 7/31/2018; CALDP/012918 Discard by 3/30/2018; CALDP/021518 Discard by 4/16/2018


Coastal Meds, LLC.

Drugs LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lots: LP/100617 Discard by 4/4/2018; LP/101817 Discard by 4/16/2018; LP/103117 Discard by 4/29/2018; LP/110817 Discard by 5/7/2018; LP/111617 Discard by 5/15/2018; LP/120617


Coastal Meds, LLC.



Firm Discard by 6/4/2018; LP/120817 Discard by 6/6/2018; LP/121417 Discard by 6/12/2018; LP/010918 Discard by 7/8/2018; LP/011818 Discard by 07/17/2018; LP/012518 Discard by 7/24/2018; LP/020818 Discard by 8/7/2018; LP/021618 Discard by 8/15/2018; CALP/021218 Discard by 4/13/2018

Drugs METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lots: MC/102017 Discard by 4/18/2018; MC/110217 Discard by 5/1/2018; MC/120517 Discard by 6/3/2018; MC/122117 Discard by 6/19/2018; MC011718 Discard by 7/16/2018; MC/012418 Discard by 7/23/2018; MC/022018 Discard by 8/19/2018; MC/021518 Discard by 4/16/2018;


Coastal Meds, LLC.



Firm CAMC/013018 Discard by 3/31/2018

Drugs PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Class II Lots: P/121517 Discard by 6/13/2018; CAP/013118 Discard by 4/1/2018; CAP/020518 Discard by 4/6/2018; CAP/021418 Discard by 4/15/2018; CAP/021918 Discard by 4/20/2018


Coastal Meds, LLC.

Drugs Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613. NDC 69623-129-10

Class II Lots: MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, MOR030518IJDSE BUD: 06/03/2018;

Lack of Assurance of Sterility: Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Premier Pharmacy Labs Inc

Drugs Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613. NDC 69623-127-10

Class II Lots: MOR022318NWDSA, MOR022318NWDSB, MOR022318NWDSC, MOR022318NWDSD, MOR022318NWDSE BUD: 05/24/2018



Drugs Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki

Class II Lots: HYD030118IJDSA, HYD030118IJDSB,

Lack of Assurance of Sterility: Microbial contamination was detected during routine testing of subsequent unreleased product lots due




Firm Wachee, FL 34613 NDC 69623-249-10

HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/2018

to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Drugs NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.

Class II Lot: NEO022218SVDS BUD: 8/21/2018



Drugs Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043

Class II Lot #: FR1603, FR1604A, Exp. 05/2018

Subpotent Drug Lyne Laboratories, Inc.

Drugs Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200

Class II Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018


Drugs Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for:

Class II Lot #: FR1601, FR1602, Exp. 05/2018




Firm Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-330-04, UPC 364980330046

Drugs Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51

Class II Lot/Batch #'s: CLZ160002, CLZ160003, CLZ160004 exp July 2018; CLZ160005, CLZ160006, CLZ160008, CLZ160009, CLZ160012, exp August 2018; CLZ160013, CLZ160014, CLZ160015, CLZ160016, exp October 2018; CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, CLZ160023, exp November 2018; CLZ170001, CLZ170002, CLZ170003, CLZ170004, CLZ170005, CLZ170006, exp March 2019; CLZ170007, CLZ170008, CLZ170009, CLZ170010, exp May 2019; CLZ170011, CLZ170012, exp June 2019; CLZ170013, CLZ170014, CLZ170015, CLZ170016, exp, September 2019; CLZ170017, exp October 2019

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

AuroMedics Pharma LLC

Drugs Levofloxacin in 5% Class II Lot/Batch #'s: Lack of Assurance of Sterility; AuroMedics



Firm Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46.

CLF160002, CLF160004, CLF160005 exp May 2018; CLF160006, CLF160007 exp June 2018; CLF170027 exp July 2019; CLF170029 exp August 2019

confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Pharma LLC

Drugs Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47.

Class II Lot/Batch #'s: CLV160016, CLV160017, and CLV160018, exp Sept 2018, CLV160019, exp Oct 2018, CLV160020, CLV160021, and CLV160031, exp Nov 2018; CLV160032 and CLV170001, exp 12/18; CLV170008 and CLV170009, exp April 2019, CLV170020, CLV170021 and CLV170022, exp Oct 2019



Drugs Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47.

Class II Lot/Batch #'s: CLV160013, CLV160014 and CLV160015, exp Sept 2018; CLV160022, CLV160023, CLV160024, CLV160025, CLV160026, CLV160027, CLV160028, CLV160029, CLV160030 exp Oct 2018;





Firm CLV170002, Dec 2018; CLV170010, exp April 2019; CLV170027, CLV170028, CLV170029 and CLV170030 exp Oct 2019

Drugs Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.

Class II Lot/Batch #'s: CLV160004, CLV160005, and CLV160006 exp September 2018; CLV170011, CLV170015, CLV170016 exp June 2019



Drugs Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47

Class II Lot/Batch #'s: CLF160008, CLF160009, CLF160010, CLF160011, exp June 2018; CLF160015, CLF160016 , CLF160017, exp August 2018; CLF170001 exp December 2018; CLF170023, CLF170024, exp May 2019; CLF170039, CLF170040, CLF170041, CLF170042, CLF170043, CLF170044, CLF170045, CLF170046, CLF170047 exp August 2019



Drugs Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For

Class II Lot/Batch #'s: CLF160012, CLF160014 exp July 2018; CLF170007,





Firm Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52

CLF170008, CLF170009, CLF170010, CLF170011, CLF170012, CLF170013 exp February 2019; CLF170014, CLF170015, CLF170016 exp March 2019; CLF170017, CLF170018, CLF170019, exp April 2019; CLF170020, CLF170021, CLF170022 exp May 2019; CLF170035, CLF170036, CLF170037, CLF170038 exp August 2019; CLF170048, CLF170049, CLF170050, CLF170051, CLF170052 exp September 2019

Drugs Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01

Class II Lot #: 7F307A, 7F307C, Exp 01/2019

Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.

Sanofi-Aventis U.S. LLC

Drugs Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only,

Class II All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Lack of Processing Controls. Kroger Specialty Pharmacy, Inc.

Drugs Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30





Firm Drugs Kalydeco 150 mg tablet

blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01



Drugs Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98



Drugs Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57



Drugs Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04



Drugs Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;



Drugs Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply



Drugs Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply



Drugs Altera Handset NDC 83490-0678-05 56 days supply



Drugs Cayston 75 mg Inh. Soln. SDV NDC 61958-

Class II All lots remaining within

Lack of Processing Controls. Kroger Specialty



Firm 0901-01 56 days supply expiry dispensed

12/01/2017 through 02/12/2018

Pharmacy, Inc.

Drugs Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply



Drugs Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;



Drugs Botox 100 Units Vial NDC 00023-1145-01 90 days supply.



Drugs Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.



Drugs Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply



Drugs Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.



Drugs Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.



Drugs Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply

Class II All lots remaining within expiry dispensed 12/01/2017




Firm through 02/12/2018

Drugs Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.



Drugs Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply



Drugs Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply



Drugs MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply.



Drugs Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.



Drugs Xolair 150 mg SDV NDC 50242-0040-62 28 days



Drugs Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply.



Drugs Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply

Class II All lots remaining within expiry dispensed 12/01/2017 through




Firm 02/12/2018

Drugs Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply



Drugs Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply



Drugs Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.



Drugs Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply



Drugs Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.



Drugs Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.



Drugs Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply



Drugs Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply





Firm Drugs Xtandi 40 mg capsule

NDC 00469-0125-99 30 days supply



Drugs Promacta 50 mg tablet NDC 00078-0686-15 30 days supply



Drugs Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply















Drugs Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply



Drugs Ibrance 125 mg cap NDC 00069-0189-21 28

Class II All lots remaining within

Lack of Processing Controls. Kroger Specialty



Firm days supply expiry dispensed

12/01/2017 through 02/12/2018

Pharmacy, Inc.

Drugs Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply



Drugs Xalkori 250 mg cap NDC 00069-8140-20 30 days supply



Drugs Temozolomide 20 mg NDC 43975-0253-05 28 days supply



Drugs Temozolomide 250 mg NDC 43975-0257-05 28 days supply



Drugs Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply



Drugs Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply



Drugs Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply



Drugs Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply

Class II All lots remaining within expiry dispensed 12/01/2017




Firm through 02/12/2018

Drugs Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply



Drugs Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply



Drugs Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply



Drugs Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply



Drugs Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply



Drugs Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply



Drugs Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply



Drugs Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply





Firm Drugs Letrozole 2.5 mg tab

NDC 51991-0759-33 30 days supply



Drugs Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply



Drugs Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply



Drugs Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply



Drugs OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply



Drugs Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply



Drugs Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply



Drugs Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090

Class II Batch # C706254, 08/2019

Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succinate Extended-Release Tablets.

Dr. Reddy's Laboratories, Inc.



Firm India\ NDC 55111-468-01

Drugs Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL

Class II Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18

Lack of Assurance of Sterility Coast Quality Pharmacy LLC

Drugs Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

Class II Part Number MEM05 and MEB30 both with expiry date 12/2018

Failed Stability Specifications Pharmalucence, Inc.

Drugs Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05

Class II Lot 6848501, EXP 04/2020

Presence of Foreign Substance: Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.

Sun Pharmaceutical Industries, Inc.

Drugs Amlodipine and Benazepril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01

Class II Lot Numbers# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019

cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure

Mylan Pharmaceuticals Inc.

Drugs Amlodipine and Benazepril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals,

Class II Lot Numbers# 3083008 and 3086124, exp Jan 2019

cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to

Mylan Pharmaceuticals Inc.



Firm Inc., Morgantown, WV --- NDC 0378-6899-01

procedure

Drugs Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176

Class II Lot # 0130126 Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15Â¿C to 30Â¿C (59Â¿F to 86Â¿F) which differs from the original manufacturer declaration of; Store at 20Â¿C to 25Â¿C (68Â¿F to 77Â¿F).

Prescript Pharmaceuticals, Inc.

Drugs Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033

Class II Lot # 0130131, EXP 8/31/20

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15Â¿C to 30Â¿C (59Â¿F to 86Â¿F) which differs from the original manufacturer declaration of; Store at 20Â¿C to 25Â¿C (68Â¿F to 77Â¿F).


Drugs Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Associates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482

Class II Lot # 130128, EXP 08/31/20



Drugs Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co.

Class II Lot # 0130132, EXP 3/31/19

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15Â¿C to 30Â¿C (59Â¿F to 86Â¿F) which differs from the original manufacturer declaration of; Store at




Firm Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11

20Â¿C to 25Â¿C (68Â¿F to 77Â¿F).

Drugs Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by: Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834

Class II Lot # 0130130 EXP 12/31/20



Drugs Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010

Class II Lot #: a) 46397, 46457 Exp 03/19; 46621, Exp 04/19; 46894, 46904, 46905, Exp 06/19; 47133, Exp 07/19; 47153, Exp 08/19; 47154, 47213, 47214, Exp 09/19; b) 46695, Exp 04/19; 46994, 47012, Exp 07/19; 47322 10/19; c) 46822, Exp 05/19 ; 47155, 47212, Exp 09/19

Defective delivery system L. Perrigo Company

Drugs B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

Class II Lot: # ET507-0, Exp. 5/27/2019; GU894-8, Exp. 7/20/2010

Microbial Contamination of Non-sterile Product

Milbar Laboratories, Inc.

Drugs Solar Defense Sheer Sunscreen Broad

Class II Lot #: KU455-2, Exp.

GMP Deviations Milbar Laboratories



Firm Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128

11/09/2020; KU455-6, Exp.11/26/2020

, Inc.

Drugs Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.

Class II Lot #: KU455-4, Exp.10/30/2020

GMP Deviations Milbar Laboratories, Inc.

Drugs MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN

Class II Lot #: KU503-6, KU393-6, Exp. 12/28/2020

GMP Deviations Milbar Laboratories, Inc.

Drugs Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02

Class II Lot Numbers: 7AT0283V, exp. 11/18 7AT0284V, exp. 11/18 7AT0285V, exp. 11/18 7FT0460, exp. 05/19 7FT0461, exp. 05/19 7GT0465, exp. 06/19 7GT0466, exp. 06/19 7JT0390, exp. 08/19 7JT0392, exp. 08/19 7KT0588, exp. 09/19 7KT0589, exp. 09/19

Failed Stability Specifications Perrigo New York

Drugs Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10

Class III Lot #: 0115086, Exp. 12/2018

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

McKesson Packaging Services

Drugs Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,

Class III Lot #: 0114214, Exp. 09/2018

Failed Dissolution Specifications. High dissolution results were obtained during stability




Firm 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10

testing.

Drugs Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10

Class III Lot #: 0115087, Exp. 12/2018

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.


Drugs Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45

Class III Lot# AG8679B Exp. 01/2020

Failed Dissolution Specification: Low dissolution outside of specifications

Rhodes Pharmaceuticals, L.P.

Drugs OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10

Class III Lot #'s D01894E and D01894G

Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.

Septodont Inc.

Drugs Ferrous Sulfate 325 MG tablet

Class III Batch ID: 57909-1, exp. date 04/30/2019 57909-2, exp. date 06/30/2019

Presence of Foreign Tablets/Capsules

Aidarex Pharmaceuticals LLC

Drugs Calendula Cream, calendula officinalis 1X

Class III Lot Numbers: M7090711,

Labeling: Labeling Error on Declared Strength; The outer

Boiron Inc.



Firm HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA

M7090712, M7090713, M7090709, M7090807, Exp: 09/2019 and M7110589, Exp: 11/2019

carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.

Drugs Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02

Class III Lot Numbers: E170210A, EXP 06/09/2019; F170214A, 07/05/2019; F170223A, EXP 07/06/2019; F170224A EXP 07/10/2019; F170231A , EXP 07/12/2019; F170232A EXP 07/13/2019.

Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

Sun Pharmaceutical Industries, Inc.

Drugs Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, packaged in 10-count vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-117-20.

Not Yet Classified

Lot #: AS0317041-A, AS0317035-A; Exp August 2019

Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.


Drugs Minivelle (estradiol transdermal system) 0.1 mg/day, packaged in 8-systems per box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6610-8

Not Yet Classified

Lot #: 81391, 81638 Exp. 10/2018

Defective Delivery System: Product is out of specification for shear

Noven Pharmaceuticals, Inc.

Drugs Minivelle (estradiol transdermal system) 0.0375 mg/day, packaged in 8-systems per box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186

Not Yet Classified

Lot #: 81896, Exp. 03/2019; 82264 Exp. 12/2018

Defective Delivery System: Product is out of specification for shear

Noven Pharmaceuticals, Inc.



Firm Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6637-8

Drugs Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30

Not Yet Classified

Lot #s: PP0317061-A, PP0317049-A; EXP August 2019

Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass


Drugs Piperacillin and Tazobactam for Injection, USP 3.375 grams/vial, Rx only, Mfg. by Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India, Mfg. for Apotex Corp. Weston, FL 33326, NDC 60505-0687-4

Not Yet Classified

Lot #: 501G014, Exp 05/2018; 501G015, Exp 09/2018; 501G016, 501G017, 501G018, 501G019, 501G020, 501G021, 501G022, 501G023, Exp 10/2018; 501G024, 501G025, 501G026, 501G027, 501G028, 501G029, 501G030, Exp 11/2018; 501H001, 501H002, 501H003, 501H004, 501H006, 501H007, 501H008, Exp 12/2018; 501H009, Exp 04/2019; 501H012, 501H013, Exp 06/2019;

Subpotent Drug Pfizer Inc.



Firm 501H018, 501H019, Exp 09/2019.

Drugs Piperacillin and Tazobactam for Injection, USP 4.5 grams/vial, Rx only, Mfg. by Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India, Mfg. for Apotex Corp. Weston, FL 33326, NDC 60505-0688-4

Not Yet Classified

Lot #: 502H001, Exp 01/2019; 502H003, 502H004, 502H005, Exp 04/2019; 502H006, 502H007, 502H008, 502H009, 502H010, 502H011, 502H012, 502H013, 502H017, Exp 05/2019; 502H022, 502H023, Exp 06/2019; 502H024, 502H026, 502H027, 502H028, Exp 07/2019.

Subpotent Drug Pfizer Inc.


CURRENT DRUG SHORTAGES

Multiple Electrolytes Large Volume Solutions For Injection April 25, 2018 Reason for the Shortage

• Baxter did not provide a reason for Plasma-Lyte 148 and Plasma-Lyte A shortage. • Pfizer had Normosol-R presentations on back order due to manufacturing delays.

Estimated Resupply Dates

• Baxter has Plasma-Lyte-A pH 7.4 500 mL bags on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=389 Hepatitis A Virus Vaccine Inactivated April 26, 2018 Reason for the Shortage

• Merck did not provide a reason for the Vaqta shortage. • GlaxoSmithKline did not provide a reason for the shortage. • GlaxoSmithKline discontinued the Havrix adult vials in November 2017.


• Merck has Vaqta pediatric/adolescent formulation 25 U/0.5 mL prefilled syringes in 10 count on back order and the company estimates a release date of 2nd quarter 2018.

• Merck has Vaqta adult formulation 50 U/1 mL in 1 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=280 Fentanyl Citrate Injection April 26, 2018 Reason for the Shortage

• Akorn has fentanyl injection on shortage due to increased demand. • West-Ward has fentanyl injection on shortage due to supply and demand issues. • Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules were

discontinued in September 2017. Estimated Resupply Dates

• Akorn has Sublimaze 50 mcg/mL 2 mL ampules in 10 count and 5 mL ampules in 10 count on intermittent back order and is allocating product upon release. Sublimaze 50 mcg/mL 2 mL ampules in 25 count and 5 mL ampules in 25 count are temporarily not being packaged.

• Pfizer has fentanyl 50 mcg/mL 2 mL and 5 mL ampules on back order and the company estimates a release date of early-June 2018 for the 2 mL ampules and May 2018 for the 5 mL ampules. The 2 mL Carpuject syringes are on back order and the company estimates a release date of June 2019. The 2 mL, 5 mL, 10 mL, 20 mL, and 50 mL vials are on back order and the company estimates a release date of May 2018 for the 2 mL, 5 mL, and 50 mL vials and June 2018 for the 10 mL and 20 mL vials.


• West-Ward has fentanyl 50 mcg/mL 2 mL, 5 mL, and 50 mL vials on allocation. The 20 mL vials are on back order and the company estimates a release date of mid- to late-May 2018. The 2 mL, 5 mL, and 20 mL ampules 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=315 Azithromycin Injection April 26, 2018 Reason for the Shortage

• Pfizer has azithromycin injection on shortage due to manufacturing delays. • AuroMedics did not provide a reason for the shortage. • Sun Pharma did not provide a reason for the shortage.


• AuroMedics has azithromycin 500 mg vials on intermittent back order and the company is releasing product as it becomes available.

• Athenex has azithromycin 500 mg vials on back order and the company estimates a release date in early-June 2018.

• Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a release date of June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=380 Vitamin K (Phytonadione) Injection April 27, 2018 Reason for the Shortage

• Pfizer has vitamin K injection on market reserve due to increased demand. The increased demand is thought to be due to increased use of synthetic inhaled cannabinoids laced with anticoagulants.

• Oral vitamin K is not affected by this shortage. Estimated Resupply Dates

• Pfizer has vitamin K injection in 1 mg/mL 0.5 mL ampules and 10 mg/mL 1 mL ampules on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=100 Thiothixene Capsules April 27, 2018 Reason for the Shortage

• Mylan did not provide a reason for the shortage. • Mylan is the sole supplier of thiothixene.


• Mylan has thiothixene 1 mg, 2 mg, 5 mg, and 10 mg capsules in 100 count bottles on back order and the company estimates a release date of late-May 2018.

• Mylan Institutional has thiothixene 2 mg, 5 mg, and 10 mg capsules in 100 count unit-dose blister packs on back order and the company estimates a release date of early-June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=418


Buprenorphine Hydrochloride Injection April 27, 2018 Reason for the Shortage

• Pfizer has buprenorphine injection on shortage due to manufacturing delays. • Par has buprenorphine injection on shortage due to increased demand.


• Par has buprenorphine 0.3 mg/mL 1 mL vials on intermittent back order with regular releases. • Pfizer has buprenorphine 0.3 mg/mL 1 mL Carpuject syringes 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=419 Theophylline Extended-Release Tablets April 30, 2018 Reason for the Shortage

• Major has discontinued theophylline extended-release tablets. • Teva cannot provide a reason for the shortage.


• Teva has theophylline extended-release tablets temporarily unavailable and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=205 Pamidronate Disodium Solution For Injection April 30, 2018 Reason for the Shortage

• Mylan Institutional did not provide a reason for the shortage. • Pfizer has pamidronate on shortage due to manufacturing delays.


• Mylan Institutional has pamidronate 3 mg/mL and 9 mg/mL 10 mL vials on back order and the company estimates a release date of early-August 2018.

• Pfizer has pamidronate 3 mg/mL 10 mL vials on back order and the company estimates a release date of May 2018. The 9 mg/mL 10 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=402 Fomepizole Injection April 30, 2018 Reason for the Shortage

• Mylan Institutional did not provide a reason for the shortage. • X-Gen has fomepizole on shortage due to increased demand.


• Mylan Institutional has fomepizole 1 gram/mL 1.5 mL vials on available for emergency drop shipment only.


• X-Gen has fomepizole 1 gram/mL 1.5 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=394

Atropine Sulfate Injection April 30, 2018 Reason for the Shortage

• American Regent had atropine injection on shortage due to market demand. • Amphastar has atropine injection available. • Pfizer has atropine injection on shortage due to manufacturing delays. • West-Ward did not provide a reason for the shortage.


• American Regent has 1 mg/mL 1 mL vials available in limited quantities. The 0.4 mg/mL 1 mL vials are on back order and the company cannot estimate a release date.

• Pfizer has atropine 0.1 mg/mL 10 mL Ansyr syringes available on back order and the company estimates a release date of June 2018. The 0.1 mg/mL 5 mL LifeShield syringes are on back order and the company estimates a release date of May 2018.

• West-Ward has atropine 0.4 mg/mL 20 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46 Amoxicillin and Clavulanate 1000 Mg/62.5 Mg Extended-Release Tablets April 30, 2018 Reason for the Shortage

• Dr. Reddy's states they are having raw ingredient issues. • Sandoz has amoxicillin/ clavulanate available.


• Dr. Reddy's has Augmentin XR and generic amoxicillin/clavulanate 1000 mg / 62.5 mg tablets temporarily unavailable and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=279 Lidocaine Injection May 01, 2018 Reason 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.


• AuroMedics has 1% lidocaine 2 mL and 5 mL ampules and 2mL, 5 mL, and 30 mL vials on intermittent back order and the company is releasing product as it becomes available.


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

• Fresenius Kabi has 0.5% Xylocaine 50 mL vials on back order and the company estimates a release date of late-June 2018. The 0.5% Xylocaine-MPF 50 mL vials are on back order and the company estimates a release date of early-May 2018. The 1% lidocaine 2 mL and 10 mL vials are on back order and the company estimates a release date of late-June 2018 for the 2 mL vials and mid-May 2018 for the 10 mL vials. The 1% Xylocaine 20 mL and 50 mL vials are on back order and the company estimates a release date of early-May 2018. The 1% Xylocaine 2 mL and 10 mL vials are on back order and the company estimates a release date of late-June 2018 for the 2 mL vials and mid-May 2018 for the 10 mL vials. The 1% Xylocaine-MPF 2 mL vials are on back order and the company estimates a release date of early-May 2018. The 1% Xylocaine-MPF 5 mL vials are on back order and the company estimates a release date of early-June 2018. The 1% Xylocaine-MPF 10 mL vial sterile packs are on back order and the company estimates a release date of late-May 2018. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company estimates a release date of mid-May 2018. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine-MPF 2 mL and 5 mL vials are on back order and the company estimates a release date of late-May 2018 for the 2 mL vials and mid-May 2018 for the 5 mL vials. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of late-May 2018. The 2% Xylocaine 10 mL, 20 mL, and 50 mL vials are on back order and the company estimates a release date of early-June 2018 for the 10 mL and 20 mL vials and early-May 2018 for the 50 mL vials. The 2% lidocaine 5 mL preservative free vials are on back order and the company estimates a release date of late-May 2018. Check wholesalers for inventory.

• Pfizer has 0.5% lidocaine 50 mL vials on back order and the company estimates a release date of June 2018. The 1% lidocaine 2 mL preservative-free ampules are on back order and the company estimates a release date of May 2018. The 1% lidocaine 5 mL preservative-free ampules are on back order and the company estimates a release date of 2019. The 1% lidocaine 20 mL vials are on back order and the company estimates a release date of May 2018. The 1% lidocaine 30 mL preservative-free vials are on back order and the company estimates a release date of May 2018. The 1% lidocaine 50 mL vials are on back order and the company estimates a release date of May 2018. The 1% lidocaine 5 ml LifeShield syringes are on back order and the company estimates a release date of June 2018. The 2% lidocaine 2 mL preservative-free ampules are on back order and the company estimates a release date of September 2018. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of 2019. The 2% lidocaine 20 mL vials are on back order and the company estimates a release date of June 2018. The 2% lidocaine 50 mL vials are on back order and the company estimates a release date of June 2018. The 2% lidocaine 10 mL ampules are on back order and the company estimates a release date of July 2018.The 2% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of May 2018. The 2% lidocaine 5 mL Ansyr syringes are available in limited supply. The 4% lidocaine 5 mL ampules are on back order and the company estimates a release date of July 2018.

• West-Ward has 1% lidocaine 5 mL preservative-free vials, 1% lidocaine 50 mL vials, and 2% lidocaine 5 mL preservative free vials on allocation. The 2% lidocaine 50 mL vials are on back order and the company estimates a release date of May 2018.



Amino Acid Products May 01, 2018 Reason for the Shortage

• Baxter has most amino acid products on allocation due to delays because of Hurricane Maria in Puerto Rico. [1]

• BBraun has all amino acid on allocation due to increased demand.[2] • Pfizer has Aminosyn on back order due to an ingredient shortage which has caused a supply

disruption. Pfizer has obtained the ingredient, but does not yet have an estimated date as to when manufacturing will resume.[3]


• Baxter has their amino acid products on allocation.[1] • BBraun has their amino acid products on allocation.[2] • ICU Medical has Aminosyn 3.5% 1000 mL bags, Aminosyn 8.5% 500 mL and 500 mL with

electrolytes bags, Aminosyn 10% 500 mL and 1000 mL bags, Aminosyn II 8.5% 500 mL and 500 mL with electrolytes bags, and Aminosyn II 10% 500 mL and 1000 mL bags on back order and the company estimates a release date of 1st quarter 2019.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=297 50% Dextrose Injection May 01, 2018 Reason for the Shortage

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


• Pfizer has 50% dextrose 50 mL LifeShield syringes available in limited supply. The 50% dextrose 50 mL vials are on back order and the company estimates a release date of May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=306 5% Lidocaine and 7.5% Dextrose Injection May 01, 2018 Reason for the Shortage

• Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on shortage due to manufacturing delays.

• Pfizer is the sole supplier of this combination. Estimated Resupply Dates

• Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on long-term back order and the company estimates a release date of 2019.



Sufentanil Injection May 02, 2018 Reason for the Shortage

• Pfizer has sufentanil injection on shortage due to manufacturing delays. • Akorn has Sufenta injection on shortage due to increased demand for the product. • West-Ward did not provide a reason for the shortage.


• Pfizer has sufentanil 50 mcg/mL 1 mL and 5 mL vials on back order and the company estimates a release date of early-August 2018 for the 1 mL vials and December 2018 for the 5 mL vials. The 2 mL vials are available in limited supply.

• Akorn has Sufenta 50 mcg/mL 1 mL, 2 mL, and 5 mL ampules on back order and the company estimates a release date of mid-May 2018.

• West-Ward has sufentanil 50 mcg/mL 5 mL ampules available with an expiration date of < July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=376 Potassium Chloride Injection May 02, 2018 Reason for the Shortage

• Baxter has their highly concentrated potassium chloride in sterile water on shortage because a manufacturing facility has been affected by Hurricane Maria. Baxter has removed these products from distribution and they can be purchased directly if they are in stock. Baxter is also adjusting the allocation of these products. 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 and manufacturing

delays. 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

• Baxter has potassium chloride 20 mEq/1000 mL in lactated ringer's and 5% dextrose on back order and the company cannot estimate a release date.

• Baxter has potassium chloride 40 mEq/100 mL and 20 mEq/50 mL in sterile water bags on back order and the company cannot estimate a release date.

• Pfizer has potassium chloride 10 mEq/5 mL vials, 20 mEq/10 mL vials, and 40 mEq/20 mL vials on back order and the company estimates a release date of June 2018.

• ICU Medical has potassium chloride 10 mEq/50 mL and 10 mEq/100 mL in sterile water on back order and the company estimates a release date of mid-May 2018.

• Fresenius Kabi has potassium chloride 10 mEq/5 mL, 20 mEq/10 mL, 40 mEq/20 mL, and 60 mEq/30 mL vials on back order and the company cannot estimate a release date.



Multiple Vitamins For Infusion May 02, 2018 Reason for the Shortage

• Pfizer states the shortage is due to manufacturing delays. • Baxter has all presentations fully available at this time.


• Pfizer has M.V.I. adult 50 mL Dual vials on back order and the company estimates a release date of June 2018. The M.V.I. 2 x 5 mL Dual vials are only available for direct orders. The 5 mL pediatric vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=69 Moxifloxacin Injection May 02, 2018 Reason for the Shortage

• Bayer discontinued Avelox IV in December 2017. • Fresenius Kabi has moxifloxacin injection on shortage due to increased demand. • Mylan Institutional did not provide a reason for the shortage.


• Fresenius Kabi has moxifloxacin 400 mg/250 mL premixed bags on back order and the company estimates a release date of late-May 2018.

• Mylan Institutional has moxifloxacin 400 mg/250 mL premixed bags on back order and the company estimates a release date of late-May to early-June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=357 Isocarboxazid Tablets May 02, 2018 Reason for the Shortage

• Validus has Marplan tablets on shortage due to manufacturing delays. Estimated Resupply Dates

• Validus has Marplan on back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=411 Iron Dextran Injection May 02, 2018 Reason for the Shortage

• Allergan has INFeD on shortage due to manufacturing delays. • American Regent discontinued Dexferrum injection in 2014.



• Allergan has INFeD 50 mg/mL 2 mL vials on back order and the company estimates a release date of late-May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=408 Fluorescein Sodium Ophthalmic Strips May 02, 2018 Reason for the Shortage

• Hub did not provide a reason for the shortage. • Akorn did not provide a reason for the shortage.


• Akorn has Ful-Glo 0.6 mg and 1 mg strips on back order and the company estimates a release date of late-May 2018.

• Hub has Bio-Glo 1 mg strips on back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=362 Diltiazem Hydrochloride Injection May 02, 2018 Reason for the Shortage

• Akorn states the reason for the shortage was increased demand due to market conditions. • Pfizer states the reasons for the shortage is manufacturing delays and increases in demand. • West-Ward has diltiazem injection on shortage due to manufacturing delays caused by

increased demand due to current market conditions. Estimated Resupply Dates

• Akorn has diltiazem 5 mg/mL 5 mL and 10 mL vials on intermittent back order and is allocating product upon release. The 25 mL vials in 1 count and 10 count are on intermittent back order and the company is allocating product upon release.

• Pfizer has 100 mg ADD-Vantage vials available in limited supply. The 5 mg/mL 5 mL and 10 mL vials are on back order and the company estimates a release date of 2019.

• West-Ward has diltiazem 5 mg/mL 5 mL vials on back order and the company estimates a release date of May 2018. The 10 mL and 25 mL vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26 2% Lidocaine Hydrochloride Topical Jelly May 02, 2018 Reason for the Shortage

• Akorn has 2% lidocaine jelly on shortage due to increased demand. • Teva discontinued lidocaine jelly in early-2018. • Glydo and Uro-Jet prefilled syringes are not affected by this shortage.


• Akorn has 2% lidocaine jelly 5 mL and 30 mL tubes on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=400


Sterile Water For Injection - Small Volume Vials May 03, 2018 Reason for the Shortage

• Pfizer has sterile water for injection in vials on shortage due to manufacturing delays. • Fresenius Kabi has sterile water on shortage due to increased demand.


• Fresenius Kabi has sterile water for injection 5 mL, 10 mL, 20 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date of mid- to late-June 2018 for the 5 mL vials, early-June 2018 for the 10 mL vials, mid May 2018 for the 20 mL vials, late-June 2018 for the 50 mL vials, and the company could not estimate a release date for the 100 mL vials. Check wholesalers for inventory.

• Pfizer has sterile water for injection 10 mL, 20 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date in May-2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=375 Methadone Injection May 03, 2018 Reason for the Shortage

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

• Mylan Institutional has methadone 10 mg/mL 20 mL vials on back order and the company estimates a release date of late-May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=358 Lidocaine Hydrochloride and 5% Dextrose Injection May 03, 2018 Reason for the Shortage

• Baxter did not provide a reason for the shortage. • BBraun did not provide a reason for the shortage.


• Baxter has lidocaine and 5% dextrose 4 mg/mL 500 mL and 8 mg/mL 250 mL premixed bags on allocation.

• BBraun has lidocaine and 5% dextrose 4 mg/mL 250 mL, 4 mg/mL 500 mL, and 8 mg/mL 250 mL premixed bags on intermittent back order and supplies are being allocated upon release.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=372 Ketamine Injection May 03, 2018 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. • West-Ward did not provide a reason for the shortage.


• Mylan Institutional has ketamine 10 mg/mL 20 mL vials on back order and the company estimates a release date of mid- to late-June 2018. The 50 mg/mL 10 mL vials are on back order and the company cannot estimates a release date. The 100 mg/mL 5 mL vials are on back order and the company estimates a release date of late-May 2018.

• Pfizer has ketamine 50 mg/mL 10 mL vials and 100 mg/mL 5 mL vials on back order and the company estimates a release date of 2019.

• West-Ward has ketamine 50 mg/mL 10 mL vials and 100 mg/mL 5 mL vials on allocation. • 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 regular releases https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=391 Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution May 03, 2018 Reason for the Shortage

• OCuSOFT has discontinued Flurox. • Altaire is the sole supplier of fluorescein/benoxinate ophthalmic solution.


• Altaire has Altafluor available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=421 Epinephrine Auto-Injectors May 03, 2018 Reason for the Shortage

• Impax was not able to provide a reason for the shortage. • Mylan has EpiPen on shortage due to supply constraints


• Impax has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on back order and the company cannot estimate a release date.

• Mylan has Epipen, EpiPen Jr, and their authorized generic presentations on intermittent back order with regular releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=420 Belatacept Injection May 03, 2018 Reason for the Shortage

• Bristol-Myers Squibb has Nulojix in short supply due to manufacturing delays.


Estimated Resupply Dates • Bristol-Myers Squibb has limited the distribution of Nulojix. They have product only for existing

patients available through the US Nulojix Distribution Program. They have no estimated recovery date, but do not expect full recovery before the end of 2018. Nulojix is distributed by McKesson Plasma Biologics.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=299 Vancomycin Hydrochloride Injection May 04, 2018 Reason for the Shortage

• Athenex has vancomycin injection available.[1] • Pfizer has vancomycin vials on back order due to manufacturing delays.[2] • Fresenius Kabi has vancomycin injection on shortage due to increased demand.[3] • Mylan Institutional has vancomycin injection available.[4] • Sagent has vancomycin injection on shortage due to manufacturing delays and increased

demand.[7] • Baxter has vancomycin injection available.[5] • Samson Medical Technologies has vancomycin injection available.[6]


• Fresenius Kabi has vancomycin 750 mg, 5 gram and 10 gram vials on intermittent back order with regular releases.3

• Pfizer has vancomycin 500 mg vials, 500 mg ADD-Vantage vials, 750 mg vials, 750 mg ADD-Vantage vials, 1 gram vials, 1 gram ADD-Vantage vials, 5 gram vials, and 10 gram vials available for direct orders only.[2]

• Sagent has vancomycin 5 gram vials on allocation. The 10 gram vials are on back order and the company estimates a release date of May 2018.[7]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 Rocuronium Injection May 04, 2018 Reason for the Shortage

• Fresenius Kabi has rocuronium on shortage due to delay of raw materials. • Pfizer has rocuronium on shortage due to manufacturing delays. • Sagent has rocuronium on shortage due to increased demand. • AuroMedics launched rocuronium in mid-2017.


• AuroMedics has rocuronium 10 mg/mL 5 mL and 10 mL vials available with intermittent releases.

• Sagent has rocuronium 10 mg/mL 5 mL and 10 mL vials on back order and the company estimates a release date of May 2018.

• X-Gen has rocuronium 10 mg/mL 5 mL and 10 mL vials on back order and the company estimates a release date of early-May 2018.



Progesterone Injection May 04, 2018 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Fresenius Kabi has progesterone on shortage due to increased demand and manufacturing

delays. • Teva has progesterone on shortage due to supply constraints. • West-Ward has progesterone on shortage due to manufacturing delays.


• American Regent has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company cannot estimate a release date.

• Fresenius Kabi has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company estimates a release date of early-July 2018.

• Teva has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company estimates a release date of mid-May 2018.

• West-Ward has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company estimates a release date of May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=381 Piperacillin and Tazobactam Injection May 04, 2018 Reason for the Shortage

• Apotex has piperacillin/tazobactam on shortage due to regulatory delays. • AuroMedics and Sandoz could not provide a reason for the shortage. • Fresenius Kabi has piperacillin/tazobactam on shortage due to increased demand. • Mylan Institutional launched piperacillin/tazobactam 3.375 gram and 4.5 gram vials in early-

June 2016. • Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing

delays. • Sagent has piperacillin/tazobactam on shortage due to increased demand. • Sandoz has piperacillin/tazobactam available for contracted customers. • WG Critical Care states the reason for the shortage is increased demand. • FDA in conjunction with SteriMax was allowing temporary importation of

piperacillin/tazobactam 3.375 gram, 4.5 gram, and 40.5 gram vials from Canada. This was being distributed through X-Gen Pharmaceuticals. These are no longer being imported with the launch of the products from X-Gen. The product codes on these items will not be recognized by U.S. systems so institutions will need to implement alternative plans to assure the dose is being given correctly. More information can be found on the FDA site at: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM543149.pdf.

• Wockhardt has piperacillin/tazobactam injection available. • X-Gen has piperacillin/tazobactam injection available.


• Apotex has piperacillin/tazobactam 3.375 gram and 40.5 gram vials on back order and the company cannot estimate a release date.


• AuroMedics has piperacillin/tazobactam 4.5 gram vials on intermittent back order and the company is releasing product as it becomes available.

• Baxter has Zosyn 2.25 gram/50 mL, 3.375 gram/50 mL, and 4.5 gram/50 mL premixed bags available in limited supply.

• Mylan has piperacillin/tazobactam 3.375 gram vials available with a short expiration date (expiration September 2018).

• 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 2019. Pfizer has piperacillin/tazobactam 3.375 gram and 4.5 gram ADD-Vantage vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=158 Methotrexate Injection May 04, 2018 Reason for the Shortage

• Accord did not provide a reason for the shortage.[1] • Fresenius Kabi has methotrexate injection available.[2] • 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.[3] • Pfizer has methotrexate injection available.[4] • Teva had methotrexate injection on shortage due to increased demand.[5] • West-Ward has methotrexate injection available.[6]


• All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282 Levetiracetam Injection May 04, 2018 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has product available. • Mylan has product available. • Pfizer has product available. • Sagent has product available. • Sun Pharma did not provide a reason for the shortage. • UCB has product available. • West-Ward has product available. • X-Gen has product available.


• American Regent has levetiracetam 100 mg/mL 5 mL vials on back order and the company cannot estimate a release date.

• AuroMedics has levetiracetam 5 mg/100 mL, 10 mg/mL 100 mL, and 15 mg/mL 100 mL premixed bags back order and the company cannot estimate a release date.


• Sun Pharma has levetiracetam 100 mg/mL 5 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=84 Indocyanine Green May 04, 2018 Reason for the Shortage

• Akorn had IC-Green on shortage due to manufacturing delays. • Hub has indocyanine green available.


• Akorn has IC-Green 25 mg kits on back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=324 Etoposide May 04, 2018 Reason for the Shortage

• Accord has etoposide on back order due to increased demand. • Fresenius Kabi has etoposide on back order due to increased demand. • Teva has Toposar on back order due to increased demand. • West-Ward did not provide a reason for the shortage. • Etoposide phosphate powder for injection (Etopophos) is unaffected by this shortage.


• Accord has etoposide 5 mL and 25 mL vials on intermittent back order and the company is releasing product as it becomes available. The 50 mL vials are on back order and the company estimates a release date of late-June 2018.

• Fresenius Kabi has etoposide 20 mg/mL 5 mL, 25 mL, and 50 mL vials on back order and the company estimates a release date of early-June 2018 for the 5 mL and 25 mL vials, and late-May 2018 for the 50 mL vials. Check wholesalers for inventory.

• Teva has Toposar 20 mg/mL 5 mL, 25 mL, and 50 mL vials on allocation. • West-Ward has etoposide 20 mg/mL 5 mL and 25 mL vials on back order and the company

cannot estimate a release date. The 50 mL vials are on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=369

Diclofenac 0.1% Ophthalmic Solution May 04, 2018 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Rising pharmaceuticals discontinued diclofenac ophthalmic solution. • Sandoz did not provide a reason for the shortage.


• Akorn has diclofenac 0.1% ophthalmic solution on long-term back order.


• Sandoz has diclofenac 0.1% ophthalmic solution in 5 mL bottles on back order and the company estimates a release date of late-May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=395 Dexrazoxane Injection May 04, 2018 Reason for the Shortage

• Cumberland Pharmaceuticals relaunched Totect in late-July 2017. • Mylan Institutional has dexrazoxane available. • Pfizer states manufacturing delay as the reason for the shortage. • West-Ward has dexrazoxane available.


• Pfizer has Zinecard 250 mg vials on allocation. The 500 mg vials are on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=107 Dalbavancin Injection May 04, 2018 Reason for the Shortage

• Allergan had Dalvance on shortage due to manufacturing delays. They are the sole suppliers of dalbavancin injection.


• Allergan has Dalvance 500 mg vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=399 Cefoxitin Sodium Injection May 04, 2018 Reason for the Shortage

• Fresenius Kabi and West-Ward did not provide a reason for the shortage. • Sagent had cefoxitin on shortage due to manufacturing delays. • BBraun has cefoxitin on allocation due to increased demand. • WG Critical Care did not provide a reason for the back order. • Apotex did not provide a reason for the shortage.


• West-Ward has cefoxitin 1 gram, 2 gram, and 10 gram vials on back order and the company estimates a release date of May 2018 for the 1 gram vials and cannot estimate a release date for the 2 gram and 10 gram vials.

• BBraun has cefoxitin 1 gram and 2 gram vials on allocation. • WG Critical Care has cefoxitin 1 gram vials on back order and the company estimates a release

date of early- to mid-May 2018.


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

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=271 Cefotaxime Sodium Injection May 04, 2018 Reason for the Shortage

• Hospira has discontinued Claforan. Sanofi-Aventis manufactured Claforan for Hospira and is no longer making the product.

• Baxter discontinued Claforan in late-2015. • West-Ward has cefotaxime on shortage due to manufacturing and issues with raw material.


• West-Ward has cefotaxime 500 mg, 1 gram, 2 gram, and 10 gram vials 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=51 Calcium Gluconate Injection May 04, 2018 Reason for the Shortage

• American Regent has calcium gluconate on shortage due to manufacturing delays. • Fresenius Kabi has calcium gluconate available with alternating short-dating due to manufacturing

process of the vials. Estimated Resupply Dates

• American Regent has calcium gluconate 100 mg/mL 50 mL and 100 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has calcium gluconate 100 mg/mL 10 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date of early-June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=150 Alcohol Dehydrated Injection (Ethanol) May 04, 2018 Reason for the Shortage

• Akorn states the back order was due to manufacturing delays. • 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.


• Akorn has dehydrated alcohol 5 mL vials on allocation. • American Regent has dehydrated alcohol 1 mL and 5 mL ampules on back order and the company

cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=274


0.9% Sodium Chloride 10 Ml, 20 Ml, and 50 Ml Preservative Free Vials and Syringes May 04, 2018 Reason for the Shortage

• Fresenius Kabi did not provide a reason for the shortage. • Pfizer has 0.9% sodium chloride preservative-free vials on shortage due to manufacturing delays.


• Fresenius Kabi has 0.9% sodium chloride preservative free 10 mL and 20 mL vials on back order and the company estimates a release date of late-May 2018 for the 10 mL vials and mid- to late-June 2018 for the 20 mL vials.

• Pfizer has 0.9% sodium chloride preservative free 10 mL LifeShield syringes on back order and the company estimates a release date of June 2018. The 10 mL, 20 mL, and 50 mL vials are on back order and the company estimates a release date of June 2018 for the 10 mL and 20 mL vials and May 2018 for the 50 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=332 Ropivacaine Injection May 07, 2018 Reason for the Shortage

• Akorn has ropivacaine on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays. • Pfizer has ropivacaine on shortage due to manufacturing delays.


• Akorn has ropivacaine 2 mg/mL 30 mL vials on back order and the company cannot estimate a release date.

• AuroMedics has ropivacaine 2 mg/mL 20 mL vials and 100 mL bottles, 5 mg/mL 20 mL and 30 mL vials, 7.5 mg/mL 20 mL vials, and 10 mg/mL 10 mL and 20 mL vials on intermittent back order and the company is releasing product as it becomes available.

• Pfizer has ropivacaine 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of September 2018 for the 10 mL vials and May 2018 for the 20 mL vials. The 5 mg/mL 30 mL vials are on back order and the company estimates a release date of May 2018. The 7.5 mg/mL 20 mL vials are on back order and the company estimates a release date of July 2018. The 10 mg/mL 10 mL and 20 mL vials are on back order and the company estimates a release date of September 2018 for the 10 mL vials and May 2018 for the 20 mL vials.

• Fresenius Kabi has Naropin 2 mg/mL 100 mL and 200 mL bottles on back order and the company estimates a release date of early-May 2018. The 2 mg/mL 100 mL and 200 mL premixed bags are on back order and the company estimates a release date of mid-May 2018. The 5 mg/mL 20 mL vials are on back order and the company estimates a release date of mid-May 2018. The 5 mg/mL 30 mL Steripak ampules are on back order and the company estimates a release date of 3rd quarter 2018. The 7.5 mg/mL 20 mL Steripak ampules are on back order and the company estimates a release date of mid-May 2018. The 10 mg/mL 10 mL and 20 mL vials are on back order and the company estimates a release date of late-May to early-June 2018 for the 10 mL vials and mid-June 2018 for the 20 mL vials. The 10 mg/mL 10 mL and 20 mL Steripak ampules are on back order and the


company estimates a release date of mid-May 2018 for the 10 mL ampules and late-May 2018 for the 20 mL ampules. Check wholesalers for inventory.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384 Meperidine Hydrochloride Injection May 07, 2018 Reason for the Shortage

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

• Pfizer has Demerol 100 mg/mL 20 mL vials and on back order and the company estimates a release date of March 2019. The 25 mg/mL 1 mL Carpuject syringes, 50 mg/mL 1 mL Carpuject syringes, 75 mg/mL 1 mL Carpuject syringes, and 100 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of March 2019. The 50 mg/mL 0.5 mL ampules are on back order and the company estimates a release date of early-August 2018. The 50 mg/mL 1 mL ampules and 30 mL vials are on back order and the company estimates a release date of early-July 2018. The 50 mg/mL 2 mL ampules are available in limited supply.

• West-Ward has 25 mg/mL 1 mL vials and 50 mg/mL 1 mL vials on back order and the company estimates a release date of May 2018. The 100 mg/mL 1 mL vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=347 Cisplatin Injection May 07, 2018 Reason for the Shortage

• Athenex has cisplatin available.[1] • Fresenius Kabi has cisplatin available.[2] • Mylan Institutional discontinued cisplatin in January 2018.[3] • Teva had cisplatin on allocation due to increased demand.[4] • WG Critical Care has cisplatin available.[5]


• Fresenius Kabi has cisplatin 1 mg/mL 100 mL vials and 200 mL vials on back order with an estimated release date of early- to mid-May 2018. The 1 mg/mL 50 mL vials are available with short-expiration dating of <7months.[2]

• WG Critical Care has 1 mg/mL 100 mL vials on back order with an estimated release date in early-May 2018.[5]



Asparaginase Erwinia Chrysanthemi May 07, 2018 Reason for the Shortage

• Jazz Pharmaceuticals has Erwinaze on shortage due to manufacturing issues. Estimated Resupply Dates

• Jazz Pharmaceuticals has Erwinaze on back order and the company estimates a release date in mid-May 2018. The company has a site where supply updates can be found and where clinicians can register to get updates emailed or texted. This is located at https://erwinazesupply.com/product-updates/.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=266 Aminocaproic Acid Injection May 07, 2018 Reason for the Shortage

• Pfizer has aminocaproic acid on shortage due to manufacturing delays. [1] Estimated Resupply Dates

• Pfizer has aminocaproic acid 250 mg/mL 20 mL vials on back order and the company estimates a release date of May 2018.[1]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=346 Acetylcysteine Oral and Inhalation Solution May 07, 2018 Reason for the Shortage

• American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

• Fresenius Kabi has acetylcysteine oral and inhalation solution available. • Pfizer has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays. • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014. • Arbor has Cetylev effervescent tablets available. These are for oral use only.


• American Regent has acetylcysteine solution 100 mg/mL 10 mL and 200 mg/mL 10 mL and 30 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has acetylcysteine solution 200 mg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of early-June 2018. The 100 mg/mL 4 mL, 10 mL and 30 mL vials are on back order and the company estimates a release date of early-June 2018.



Methocarbamol Tablets May 08, 2018 Reason for the Shortage

• No supplier provided a reason for the shortage. Estimated Resupply Dates

• Camber has all methocarbamol tablet presentations on back order and the company estimates a release date of early-June 2018.

• Par has methocarbamol 750 mg tablets in 100 count, 500 count, and 1000 count on back order and the company cannot estimate a release date.

• Solco has methocarbamol 750 mg tablets in 100 count and 500 count on back order and the company cannot estimate a release date. Methocarbamol 500 mg tablets in 100 count are available in limited supply.

• Virtus has methocarbamol 500 mg tablet in 100 count and 500 count on back order and the company estimates a release date of late-May 2018. Methocarbamol 750 mg tablets in 100 count and 500 count are on back order and the company estimates a release date of late-May 2018 for the 100 count and July 2018 for the 500 count.

• West-Ward has methocarbamol 750 mg tablets in 100 count and 500 count on back order and the company cannot estimate a release date. Methocarbamol 500 mg tablets in 100 count and 500 count are on allocation.

• Endo has Robaxin 500 mg and 750 mg tablets in 100 count on back order and the company estimates a release date of mid-June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=423 Ipratropium Bromide Metered-Dose Inhaler May 08, 2018 Reason for the Shortage

• Boehringer Ingelheim has Atrovent HFA on shortage due to production delays. Estimated Resupply Dates

• Boehringer Ingelheim has Atovent HFA metered-dose inhalers on back order and the company estimates a release date of early-June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=422 Fluconazole Injection May 09, 2018 Reason for the Shortage

• Baxter, Renaissance Lakewood Pharmaceuticals, and West-Ward did not provide a reason for the fluconazole injection shortage.

• Pfizer has fluconazole injection on shortage due to manufacturing delays. • Renaissance Lakewood Pharmaceuticals bought fluconazole in sodium chloride premixed bags from

Claris Lifescience. Estimated Resupply Dates


• Baxter has 200 mg/100 mL and 400 mg/200 mL in 0.9% sodium chloride premixed bags on back order and the company cannot estimate a release date.

• Renaissance Lakewood has fluconazole injection 100 mg/50 mL in 0.9% sodium chloride in 10 count, 200 mg/100 mL in 0.9% sodium chloride in 6 count, and 400 mg/200 mL in 0.9% sodium chloride in 10 count on back order and the company cannot estimate a release date.

• West-Ward has all presentations on back order. The company cannot estimate a release date for any of the presentations except for the 200 mg/100 mL in 5% dextrose premixed bags, which have an estimated release date of June to July 2018.

• Pfizer has fluconazole 200 mg/100 mL in 5% dextrose premixed bags and 400 mg/200 mL in 5% dextrose premixed bags on back order. The company cannot estimate a release date for the 200 mg/100 mL in 5% dextrose premixed bags, and the company estimates a release date of October 2018 for the 400 mg/200 mL in 5% dextrose premixed bags.

• Sagent has fluconazole 200 mg/100 mL 200 mL in 0.9% sodium chloride premixed bags on back order and the company estimates a release date in May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=318 Dexmedetomidine Hydrochloride Injection May 09, 2018 Reason for the Shortage

• Athenex has dexmedetomidine vials available. • Fresenius Kabi has dexmedetomidine vials available. • Mylan has dexmedetomidine vials available. • Pfizer did not provide a reason for the shortage. • Sandoz has dexmedetomidine vials available. • Teva has dexmedetomidine vials available. • West-Ward has dexmedetomidine vials available.


• Pfizer has Precedex 4 mcg/mL 50 mL premixed bottles on back order and the company estimates a release date of May 2018. Precedex 4 mcg/mL 20 mL vials and 100 mL premixed bottles are on allocation. Precedex 100 mcg/mL 2 mL vials are on back order and the company estimates a release date in May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=398 Ciprofloxacin Oral Suspension May 09, 2018 Reason for the Shortage

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


• Lupin has ciprofloxacin oral suspension on long-term back order and the company cannot estimate a release date.



5% Dextrose Injection May 09, 2018 Reason for the Shortage

• ICU Medical states the shortage was due to increased demand. • ICU Medical is now the IV fluid business of Pfizer after the acquisition of Hospira. • Baxter did not provide a reason for the shortage.


• Baxter has 5% dextrose 250 mL, 500 mL, and 1,000 mL bags on allocation. • ICU Medical has 5% dextrose 250 mL ADD-Vantage bags and 1000 mL bags available in limited

supply. The 250 mL 2 port bags (NDC 00409-7922-53) and 500 mL bags are on intermittent back order and the company is releasing supplies as they become available. The 250 mL 2 port bags (NDC 00409-7922-02) are on back order and the company estimates a release date in mid-May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=303 Lorazepam Oral Solution May 10, 2018 Reason for the Shortage

• Shortage reasons were not provided. Estimated Resupply Dates

• Amneal has lorazepam 2 mg/mL 30 mL bottles on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=386 Lorazepam Injection May 10, 2018 Reason for the Shortage

• Bedford discontinued lorazepam injection in May, 2011.[1] • West-Ward has product on shortage due to manufacturing delays.[2] • Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer

discontinued 4 mg/mL 10 mL vials in December 2017.[3] • Akorn has not provided a reason for the shortage.[4] • Amphastar has product available.[5]


• Pfizer has lorazepam 2 mg/mL 1 mL Carpuject syringes on back order and the company cannot estimate a release date. The 2 mg/mL 10 mL vials are on back order and the company estimates a release date of June 2018. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of May 2018. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of 2019.[3]

• West-Ward has lorazepam 2 mg/mL 1 mL vials on allocation. The 2 mg/mL 10 mL vials are on back order and the company estimates a release date of May to June 2018. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of May to June 2018. The 4 mg/mL 10 mL vials are on back order and the company estimates a release date of June to July 2018.[2]


• West-Ward has Ativan 2 mg/mL 1 mL and 10 mL vials on back order and the company estimates a release date of June to July 2018. Ativan 4 mg/mL 1 mL and 10 mL vials are on back order and the company estimates a release date of May to June 2018.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87 Furosemide Injection May 10, 2018 Reason for the Shortage

• American Regent is not actively marketing furosemide injection. • Amneal did not provide a reason for the shortage. • Claris has furosemide injection available. • Fresenius Kabi did not provide a reason for the shortage. • Heritage has furosemide injection available. • Pfizer has furosemide injection on shortage due to manufacturing delays and increased demand.


• Amneal has furosemide 10 mg/mL 2 mL vials available with a short expiration date (November 2018). • Fresenius Kabi has furosemide 10 mg/mL 10 mL vials on back order and the company cannot

estimate a release date. • Pfizer has furosemide 10 mg/mL 4 mL syringes on back order and the company estimates a release

date of June 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=323 Doxorubicin Injection May 10, 2018 Reason for the Shortage

• West-Ward has Adriamycin available.[1] • Teva has doxorubicin solution for injection on shortage due to increased demand.[2-3] • Fresenius Kabi has doxorubicin solution for injection available.[4] • Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials.[5] • Pfizer has doxorubicin on shortage due to manufacturing delays.[6] • Sagent discontinued doxorubicin solution for injection in late-2017.[7] • Mylan Institutional has doxorubicin lyophilized powder for injection available.[8] • Athenex has doxorubicin available.[9] • 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.[10-11]


• Mylan Institutional has doxorubicin lyophilized powder 10 mg vials on back order and the company cannot estimate a release date. The 50 mg vials are available with an expiration date of January 2019.[8]


• Pfizer has doxorubicin 2 mg/mL 75 mL vials on back order and the company estimates a release date in June 2018.[6]

• Teva has doxorubicin 2 mg/mL 25 mL vials (NDC 45963-0733-68) and 100 mL vials (NDC 45963-0733-60) on back order and the company will allocate these as they become available.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=108 Desiccated Thyroid Tablets May 10, 2018 Reason 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.


• 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 Clindamycin Phosphate Injection May 10, 2018 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Alvogen did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage. • Pfizer has Cleocin available. • Sagent had clindamycin on shortage due to manufacturing delays. • Sandoz has clindamycin injection available.


• Alvogen has clindamycin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage presentations on back order and the company cannot estimate a release date.

• Pfizer has Cleocin 150 mg/mL 6 mL ADD-Vantage vials on back order and the company estimates a release date in July 2018. Cleocin 150 mg/mL 4 mL vials, 900 mg/50 mL in 5% dextrose premixed bags, and 600 mg/50 mL in 5% dextrose premixed bags are available in limited quantities.

• Sagent has clindamycin 150 mg/mL 2 mL, 4 mL, and 6 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=97 Ceftazidime Injection May 10, 2018 Reason for the Shortage

• Pfizer has Tazicef available. • Sagent had ceftazidime injection on shortage due to manufacturing delays. • Sandoz discontinued ceftazidime 1 gram and 2 gram vials in 2015. Sandoz discontinued the 6 gram

vials in early 2016.


• 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. • WG Critical Care has ceftazidime available.


• Pfizer has Tazicef 1 gram ADD-Vantage vials on back order and the company estimates a release date of June 2018.

• BBraun has ceftazidime 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation. • Teligent has Fortaz 500 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=63 3% and 5% Sodium Chloride Large Volume Injection May 10, 2018 Reason for the Shortage

• Baxter has 3% and 5% sodium chloride large volume for injection available. • BBraun did not provide a reason for the shortage.


• BBraun has 3% sodium chloride 500 mL bags and 5% sodium chloride 500 mL bags on allocation to current customers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=415 Vincristine Sulfate Injection May 11, 2018 Reason for the Shortage

• Pfizer has vincristine on shortage due to manufacturing delays. • Teva has Vincasar available.


• Pfizer has vincristine 1 mg/mL 2 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=382 Potassium Phosphate Injection May 11, 2018 Reason 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.


• All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=305


Metoclopramide Injection May 11, 2018 Reason for the Shortage

• Pfizer has metoclopramide injection on shortage due to manufacturing delays. • Teva has metoclopramide injection on shortage due to increased demand. • Fresenius Kabi has 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 2018.

• Teva has metoclopramide 5 mg/mL 2 mL vials on allocation. • Fresenius Kabi has metoclopramide 5 mg/mL 2 mL syringes on back order and the company

estimates a release date of early-July 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=338 Mepivacaine Injection May 11, 2018 Reason for the Shortage

• Fresenius Kabi has Polocaine and Polocaine-MPF available. • Pfizer states the reason for the shortage is manufacturing delays.


• Fresenius Kabi has Polocaine 1% 50 mL multiple-dose vials on back order and the company estimates a release date of late-May 2018.

• Pfizer has Carbocaine 2% 20 mL preservative-free vials, 1% 30 mL preservative-free vials, and 1.5% 30 mL preservative-free vials on back order and the company estimates a release date of 2019. The 1% 50 mL multiple-dose vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=331 Mannitol Injection May 11, 2018 Reasons for the Shortage

• American Regent did not provide a reason for the mannitol shortage. • Baxter did not provide a reason for the mannitol shortage. • Fresenius Kabi has mannitol on shortage due to increased demand. • Pfizer has mannitol on shortage due to manufacturing delays.


• American Regent has mannitol 250 mg/mL 50 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has mannitol 250 mg/mL 50 mL vials on back order and the company estimates a release date of late-May 2018. Check wholesalers for supply.

• Pfizer has mannitol 250 mg/mL 50 mL vials on back order and the company estimates a release date of July 2018.

• BBraun has mannitol 200 mg/mL 250 mL and 500 mL premixed bags on allocation to current customers.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=341 Magnesium Sulfate Injection May 11, 2018 Reason for the Shortage

• American Regent has had magnesium sulfate unavailable since late 2012. • Fresenius Kabi has 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 did not provide a reason for the shortage.


• Fresenius Kabi has magnesium sulfate 500 mg/mL 2 mL, 10 mL, 20 mL and 50 mL vials on back order and the company estimates a release date of late-June 2018 for the 2 mL and 10 mL vials, early-June for the 20 mL vials, and late-May 2018 for the 50 mL vials. The 40 mg/mL 100 mL and 500 mL premixed bags are on back order and the company estimates a release date of mid-June 2018 for the 100 mL bags and early-August 2018 for the 500 mL bags. The 40 mg/mL 50 mL premixed bags are available with expiration dates of <6 months. The 40 mg/mL 1,000 mL premixed bags are available with expiration dates of <1 month.

• Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of 2019. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of September 2018. The magnesium sulfate 40 mg/mL 50 mL and 1000 mL bags are on back order and the company estimates a release date of May 2018 for the 50 mL bags and June 2018 for the 1000 mL bags. The 40 mg/mL 100 mL bags are available in limited supply.

• X-Gen has 500 mg/mL 10 mL vials 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=21 Heparin Injection May 11, 2018 Reason for the Shortage

• Fresenius Kabi did not provide a reason for the shortage. • Pfizer did not provide a reason for the shortage. • Sagent had heparin on shortage due to manufacturing delay. • West-Ward did not provide a reason for the shortage


• Fresenius Kabi has 5,000 unit/mL 10 mL vials on back order and the company estimates a release date in mid-May 2018.

• Pfizer has 10,000 unit/mL 0.5 mL Carpuject syringes on back order and the company cannot estimate a release date. The 5,000 unit/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of 2019. The 1,000 unit/mL 10 mL vials are on back order and the company estimates a release date in June 2018. The 10,000 unit/mL 1 mL vials, and 1000 unit/mL 30 mL vials are on back order and the company cannot estimate a release date. The 5,000 unit/mL 1 mL vials are available in limited quantities.

• West-Ward 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 2 mL vials are on allocation.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=353 Fluorouracil Injection May 11, 2018 Reason for the Shortage

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


• Accord had fluorouracil 50 mg/mL 10 mL, 20 mL, 50 mL, and 100 mL vials on intermittent back order and the company is releasing product as it becomes available.

• Fresenius Kabi has fluorouracil 50 mg/mL 10 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date of late-May 2018 for the 10 mL and 100 mL vials and mid-June 2018 for the 50 mL vials.

• Teva has Adrucil 10 mL, 50 mL, and 100 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=401 Etomidate Injection May 11, 2018 Reason for the Shortage

• American Regent did not provide a reason for the current shortage. • AuroMedics has etomidate available. • Mylan did not provide a reason for the current shortage. • Par Sterile Products discontinued etomidate in early 2015. • Pfizer has Amidate on shortage due to manufacturing delays. Pfizer discontinued etomidate ampules

in October 2016. • Sagent is no longer marketing etomidate. • West-Ward has etomidate available. • Zydus had etomidate on shortage due to an increase in demand.


• American Regent has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company cannot estimate a release date.

• Mylan Institutional has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of late-October to early-November 2018.

• Pfizer has Amidate 2 mg/mL 20 mL LifeShield syringes on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=147 Estradiol Valerate Injection May 11, 2018 Reason for the Shortage

• Perrigo did not provide a reason for the shortage.


Estimated Resupply Dates • Perrigo has estradiol valerate 20 mg and 40 mg vials on back order and the company estimates a

release date of August 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=424 Epinephrine Injection May 11, 2018 Reason 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.[1]

• Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017.[2] • BPI has epinephrine 1 mg/mL 2 mL ampules available.[3] • Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.[4]


• Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation.[1] • Pfizer has epinephrine 0.1 mg/mL 10 mL syringes on back order and the company estimates a release

date of June 2018.[2] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313 Dipyridamole Injection May 11, 2018 Reason for the Shortage

• West-Ward did not provide a reason for the shortage.

Estimated Resupply Dates • West-Ward has dipyridamole 5 mg/mL 10 mL vials on a weekly allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=345 Butorphanol Tartrate Injection May 11, 2018 Reason for the Shortage

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

• Pfizer has butorphanol 2 mg/mL 1 mL vials on back order and the company estimates a release date of mid-August 2018. The 1 mg/mL 1 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=414 Bumetanide Injection May 11, 2018 Reason for the Shortage

• Pfizer has bumetanide injection on shortage due to manufacturing delays.


• West-Ward did not provide a reason for the shortage. Estimated Resupply Dates

• Pfizer has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of 2019.

• West-Ward has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on a weekly allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=307 Belladonna and Opium Suppositories May 11, 2018 Reason for the Shortage

• Perrigo has belladonna and opium suppositories on shortage because they are waiting to get more raw ingredient.


• Perrigo has belladona and opium 16.3mg/60 mg suppositories on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=425 Ammonium Molybdate Injection May 11, 2018 Reason for the Shortage

• American Regent has ammonium molybdate injection on shortage due to manufacturing delays. • American Regent is the sole supplier to ammonium molybdate injection


• American Regent has ammonium molybdate injection 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=11 Sodium Phosphate Injection May 14, 2018 Reason for the Shortage

• American Regent has sodium phosphate injection on shortage due to manufacturing delay.[1] • Fresenius Kabi states the reason for the shortage is increased demand.[2] • Pfizer has sodium phosphate injection on shortage due to manufacturing delay.[3]


• American Regent has sodium phosphate 3 mmol/mL 5 mL, 15 mL, and 50 mL vials on back order and the company cannot estimate a release date.[1]

• Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a release date of 2019.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=227 Oxacillin Sodium Injection May 14, 2018


Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Baxter had oxacillin on shortage due to manufacturing delays. • Sagent has oxacillin on shortage due to manufacturing delays.


• AuroMedics has all oxacillin presentations on long-term back order and the company cannot estimate a release date.

• Sagent has oxacillin 1 gram vials on back order and the company estimates a release date of May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=377 Nalbuphine Injection May 14, 2018 Reason for the Shortage

• Pfizer has nalbuphine or shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has nalbuphine 10 mg/mL 1 mL ampules on back order and the company estimates a release date of late-May 2018. The 20 mg/mL 1 mL ampules are on back order and the company estimates a release date of mid-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=409 Metronidazole Hydrochloride Injection May 14, 2018 Reason for the Shortage

• Pfizer has metronidazole injection on shortage due to manufacturing delay. • BBraun did not provide a reason for the metronidazole injection shortage.


• BBraun has metronidazole 100 mL bags on allocation to current customers. • Pfizer has metronidazole 100 mL bags in 24 count and 80 count on back order and the company

estimates a release date of June 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=316 Metoprolol Injection May 14, 2018 Reason for the Shortage

• Alvogen has metoprolol injection available.[1] • American Regent has had metoprolol injection on long-term back order for several years.[2] • Athenex has metoprolol injection available.[3] • Claris did not provide a reason for the shortage.[4] • Fresenius Kabi has metoprolol injection on shortage due to increased demand.[5]


• Mylan Institutional acquired metoprolol injection from Sagent. They discontinued metoprolol injection in March 2018.[6]

• Pfizer has metoprolol injection on shortage due to manufacturing delays.[7] • West-Ward has metoprolol injection available.[8]


• Baxter (formerly Claris) has metoprolol 1 mg/mL 5 mL vials on back order and the company cannot estimate a release date.[4]

• Fresenius Kabi has metoprolol 1 mg/mL 5 mL vials on back order and the company cannot estimate a release date.[5]

• Pfizer has metoprolol 1 mg/mL 5 mL ampules and 1 mg/mL 5 mL Carpuject syringes on back order and the company estimates a release date of 2019. The 1 mg/mL 5 mL vials are available in limited supply.[7]

• West-Ward has metoprolol 1 mg/mL 5 mL vials on allocation.[8] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=363 Methylphenidate Extended-Release Oral Suspension and Chewable Tablets May 14, 2018 Reason for the Shortage

• Pfizer has Quillivant XR on shortage due to manufacturing delays. • Pfizer has QuillChew ER chewable tablets available.


• Pfizer has Quillivant XR 5 mg/mL extended-release oral suspension in 60 mL bottles on back order and the company estimates a release date of June 2018. The QuilliChews 20 mg chewable tablets are on back order and the company estimates a release date of mid-June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=373 Leuprolide Acetate 14-Day Kit May 14, 2018 Reason for the Shortage

• Sun Pharma did not provide a reason for the shortage. • Sandoz states the reason for the shortage was increased demand. • Teva states the shortage is due to manufacturing delays.


• Sandoz has leuprolide acetate injection on back order and the company estimates a release date of late-May 2018.

• Teva has leuprolide acetate injection on long-term back order and the company cannot estimate a release date.

• Sun Pharma has leuprolide acetate injection on back order and the company cannot estimate a release date.



Leucovorin Calcium Injection May 14, 2018 Reason for the Shortage

• Fresenius Kabi has leucovorin available. • Sagent has leucovorin on shortage due to manufacturing delays. • Teva has leucovorin available. • West-Ward did not provide a reason for the current shortage.

Estimated Resupply Dates • Fresenius Kabi has leucovorin 200 mg vials on back order and the company expects a release date of

late-May 2018. • Sagent has leucovrin 350 mg vials on allocation. • West-Ward has leucovorin 350 mg vials on allocation. The 50 mg, 100 mg, and 200 mg vials are on

back order and the company estimates a release date of June to July 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Dopamine Hydrochloride Injection May 14, 2018 Reason for the Shortage

• American Regent has dopamine on shortage due to manufacturing delays. • 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

• American Regent has all dopamine presentations on back order and the company cannot estimate a release date.

• Pfizer has dopamine 40 mg/mL 10 mL vials on back order and the company estimates a release date of 2019. The 400 mg/250 mL bags are on back order and the company estimates a release date of June 2018. The 800 mg/250 mL premixed bags are on back order and the company estimates a release date of June 2018. The 800 mg/500 mL bags are available in limited supply. The 40 mg/mL 5 mL vials are on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=246 Dobutamine Injection May 14, 2018 Reason for the Shortage

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


• Baxter has dobutamine 2 mg/mL 250 mL bags on back order and the company cannot estimate a release date.

• Pfizer has dobutamine 12.5 mg/mL 20 mL and 40 mL latex-free vials on back order with an estimated release date of 2019 for the 20 mL vials and 2018 for the 40 mL vials. The 12.5 mg/mL 20 mL regular


vials in 1 count and 10 count are on back order and the company estimates a release date of June 2018.

• Pfizer has dobutamine 1 mg/mL in 250 mL bags on back order and the company estimates a release date of June 2018. The dobutamine 2 mg/mL 250 mL bags are on back order and the company estimates a release date of May 2018. The dobutamine 4 mg/mL 250 mL bags are on back order and the company estimates a release date of July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=296 Bupivacaine With Epinephrine Injection May 14, 2018 Reason for the Shortage

• 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-MPF with epinephrine 10 mL vials available with an expiration date of <5 months. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of mid- to late-June 2018. The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of mid-May 2018. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of late-June 2018. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-May 2018. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-May 2018. The 0.75% Sensorcaine with epinephrine 30 mL vials are on back order and the company cannot estimate a release date.

• Pfizer has 0.25% bupivacaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of June 2018. The 0.25% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2018. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of July 2018. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of 2019. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2018. The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2018.

• Pfizer has 0.25% Marcaine with epinephrine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of 2019. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 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 2019. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 2019.



Atenolol Tablets May 14, 2018 Reason for the Shortage

• Mylan, Sandoz, and Teva did not provide a reason for the back order. • Zydus states increased demand as the reason for the back order. • Ranbaxy refuses to provide us with any information regarding drug availability. • Major discontinued atenolol 25 mg unit-dose tablets.


• Teva has atenolol 25 mg in 100 count and 100 mg in 500 count on back order and the company estimates a release date of late-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=334 Ampicillin Sodium and Sulbactam Sodium Injection May 14, 2018 Reason for the Shortage

• Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-Vantage vials. These are on shortage due to manufacturing delays.

• Sagent had ampicillin sulbactam vials on back order due to manufacturing delays. • Sandoz cannot provide a reason for the shortage. • WG Critical Care states the shortage was 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.

• Mylan Institutional has ampicillin sulbactam 15 gram vials on back order and the company estimates a release date of late-June 2018.

• Pfizer has ampicillin sulbactam 1.5 gram and 3 gram ADD-Vantage vials on back order and the company estimates a release date of June 2018.

• Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials temporarily unavailable and the company cannot estimate a release date.

• West-Ward has ampicillin sulbactam 3 gram vials on allocation. The 1.5 gram and 15 gram vials are on back order and the company estimates a release date of June to July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 23.4% Sodium Chloride Injection May 14, 2018 Reason for the Shortage

• 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.



• Fresenius Kabi has 23.4% sodium chloride 30 mL and 100 mL vials on back order and the company estimates a release date of early-June 2018.

• Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release date of May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336 Trace Elements Injection May 15, 2018 Reason for the Shortage

• American Regent is focusing on marketing Multitrace presentations. Estimated Resupply Dates

• All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=319 Thiamine Injection May 15, 2018 Reason for the Shortage

• Fresenius Kabi had thiamine injection on shortage due to short-term manufacturing delays. • Mylan Institutional did not provide a reason for the shortage.


• Fresenius Kabi has thiamine 100 mg/mL 2 mL vials on back order and the company estimates a release date of late-May 2018. Check wholesalers for inventory.

• Mylan Institutional has thiamine 100 mg/mL 2 mL vials on back order and the company estimates a release date of ;late-June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=387 Potassium Acetate Injection May 15, 2018 Reason for the Shortage

• 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 20 mL vials on back order and the company estimates a release date of June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=344 Morphine Injection May 15, 2018 Reason for the Shortage

• 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.[1-2]


• Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.[2]

• Pfizer states the shortage is due to manufacturing delays. Pfizer discontinued morphine ADD-Vantage vials in January 2017.[3]

• Pfizer anticipates 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. Pfizer expects the shortage of prefilled syringe products to recover by late-first quarter 2018.[3]

• West-Ward did not provide a reason for the shortage. West-Ward is not actively marketing the 15 mg/mL 1 mL vials or the 8 mg/mL 1 mL vials (NDC 00641-6075-25). They are still marketing the 8 mg/mL 1 mL vials with NDC 00641-6126-25.[4]


• Fresenius Kabi has morphine 2 mg/mL 1 mL syringes on back order and the company estimates a release date of late-May 2018. The morphine 4 mg/mL 1 mL and 5 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date. Check wholesalers for inventory.[2]

• Pfizer has morphine 2 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of May 2018. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company cannot estimate a release date. The 0.5 mg/mL and 1 mg/mL 10 mL preservative-free vials are on back order and the company estimates a release date of early-June 2018 for the 0.5 mg/mL 10 mL vials and mid-June 2018 for the 1 mg/mL 10 mL vials. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1 mL Carpuject syringes, 8 mg/mL 1 mL iSecure syringes, 10 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of June 2019. The 25 mg/mL 1 mL preservative-free vials are on back order and the company estimates a release date of late-May 2018. The 50 mg/mL 20 mL and 50 mL vials are on back order and the company estimates a release date of early-June 2018 for the 20 mL vials and late-May 2018 for the 50 mL vials.[3]

• West-Ward has morphine 4 mg/mL 1 mL vials, 8 mg/mL 1 mL vials, and 10 mg/mL 1 mL vials on allocation. Infumorph 10 mg/mL 20 mL ampules and 25 mg/mL 20 mL ampules are on back order and the company cannot estimate a release date. Duramorph 1 mg/mL 10 mL ampules are on back order and the company cannot estimate a release date. Duramorph 0.5 mg/mL 10 mL ampules are on allocation.[4]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Hydromorphone Hydrochloride Injection May 15, 2018 Reason for the Shortage

• Akorn has hydromorphone injection on shortage due to increased demand.[1] • Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing their

product on the 0.5 mg strength.[2] • Pfizer did not provide a reason for the shortage.[3] • Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.[4] • Teva did not provide a reason for the shortage.[5] • West-Ward did not provide a reason for the shortage.[6]


• Akorn has hydromorphone 10 mg/mL 1 mL ampules, 5 mL ampules, and 50 mL vials on allocation.[1]


• Fresenius Kabi has Dilaudid 0.5 mg/mL 0.5 mL syringes on back order and the company estimates a release date of mid-May 2018. The 1 mg/mL 1 mL syringes and 2 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date.[2]

• Pfizer has 2 mg/mL 1 mL vials on back order and the company estimates a release date of late-June 2018. The 10 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-May 2018. The 10 mg/mL 5 mL are on back order and the company estimates a release date of mid-July 2018. The 10 mg/mL 50 mL vials are on back order and the company estimates a release date of late-June 2018. The 1 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of May 2019. The 2 mg/mL 1 mL Carpuject syringes, 0.5 mg/0.5 mL 0.5 mL iSecure syringes, 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 cannot estimate a release date. 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 June 2019.[3]

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

• West-Ward has hydromorphone 2 mg/mL 1 mL vials on allocation. The 2 mg/mL 20 mL vials are on back order and the company estimates a release date of mid-May 2018.[6]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329 Dexamethasone Sodium Phosphate Injection May 15, 2018 Reason for the Shortage

• American Regent has dexamethasone sodium phosphate on shortage due to manufacturing delays. • AuroMedics has dexamethasone sodium phosphate on intermittent back order. • Fresenius Kabi has dexamethasone sodium phosphate presentations available. • Mylan Institutional did not provide a reason for the shortage. • West-Ward has dexamethasone sodium phosphate available.


• American Regent has dexamethasone sodium phosphate 4 mg/mL products on back order and the company cannot estimate a release date.

• AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 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 mid-August 2018.

• Mylan Institutional has dexamethasone 4 mg/mL 1 mL and 5 mL vials on back order and the company estimates a release date of early-June 2018 for the 1 mL vials and mid- to late-June 2018 for the 30 mL vials.

• West-Ward has dexamethasone sodium phosphate 4 mg/mL 1 mL and 5 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=140 Deferoxamine Injection May 15, 2018 Reason for the Shortage

• Fresenius Kabi has deferoxamine on shortage due to increased demand. • Pfizer has deferoxamine on shortage due to manufacturing delays.


• Novartis has Desferal on shortage due to increased demand. Estimated Resupply Dates

• Fresenius Kabi has deferoxamine 500 mg and 2 gram vials on back order and the company estimates a release date of late-May 2018. Check wholesalers for inventory.

• Pfizer has deferoxamine 500 mg and 2 gram vials on back order and the company estimates a release date of 2019. Pfizer has a limited supply of short-dated 2 gram vials.

• Novartis has Desferal 500 mg vials on allocation https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=393 Ciprofloxacin Injection May 15, 2018 Reason for the Shortage

• Pfizer has ciprofloxacin injection on shortage due to manufacturing delays. • Baxter (formerly Claris) has ciprofloxacin injection available.


• Pfizer has ciprofloxaxin 2 mg/mL 100 mL and 200 mL premixed bags on back order and the company estimates a release date of June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=396 Chlorothiazide Sodium Injection May 15, 2018 Reason for the Shortage

• Akorn has chlorothiazide injection on shortage due to manufacturing delays. • Sagent has chlorothiazide injection on shortage due to increased demand. • Sun Pharma refuses to provide availability information on any of their products.


• American Regent has chlorothiazide 500 mg vials on back order and the company cannot estimate a release date.

• Mylan Institutional has chlorothiazide 500 mg vials on back order and the company estimates a release date of late-May 2018.

• Sagent has chlorothiazide 500 mg vials on allocation. • Sun Pharma has chlorothiazide 500 mg vials on back order and the company cannot estimate a

release date. • Akorn has chlorothiazide 500 mg vials on back order and the company is allocating product upon

release. • Akorn has Sodium Diuril 500 mg vials on back order and the company is allocating product upon

release. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=365 Tobramycin Sulfate Injection May 16, 2018 Reason for the Shortage

• Akorn has tobramycin injection on shortage due to manufacturing delays.


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

• Akorn has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company cannot estimate a release date. There may be short-dated 2 mL vials available.

• Baxter (formerly Claris) has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company cannot estimate a release date.

• Mylan Institutional has tobramycin 40 mg/mL 2 mL vials on back order and the company estimates a release date of late-May 2018.

• Teva has temporarily discontinued tobramycin 40 mg/mL 2 mL vials. • Fresenius Kabi has tobramycin 1.2 gram powder for injection on back order and the company

estimates a release date of mid-June 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=164 Ranitidine Injection May 16, 2018 Reason for the Shortage

• Teligent has Zantac IV on shortage due to production delays. • Zydus has ranitidine injection on allocation due to increased demand.


• Zydus has ranitidine 25 mg/mL 2 mL and 6 mL vials on allocation. • Teligent has Zantac 25 mg/mL 2 mL vials on back order and the company estimates a release date of

4th quarter 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=426 Prothrombin Complex Concentrate (Kcentra) May 16, 2018 Reason for the Shortage

• CSL Behring had short-term delays in product releases. Estimated Resupply Dates

• CSL Behring is releasing Kcentra weekly. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=404 Octreotide Injection May 16, 2018 Reason for the Shortage

• Fresenius Kabi has octreotide available. • Mylan Institutional has octreotide available. • Sagent has octreotide on shortage due to manufacturing delays. • Sun Pharma did not provide a reason for the shortage. • Teva has octreotide available. • Novartis has Sandostatin available. The 200 mcg/mL 5 mL vials were discontinued in early-2018. • West-Ward has octreotide available.


Estimated Resupply Dates • Fresenius Kabi has octreotide 50 mcg/mL 1 mL vials on back order and the company estimates a

release date of 2nd quarter 2018. • Sun Pharma has all octreotide presentations on back order and the company cannot estimate a

release date. • West-Ward has all presentations on available but with short expiration dating.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=229 Lactated Ringer's Injection May 16, 2018 Reason for the Shortage

• Baxter did not provide a reason for the shortage. • BBraun states the reason for the shortage is increased demand. • ICU Medical states the reason for the shortage is increased demand.


• Baxter has lactated ringer's 250 mL, 500 mL, and 1000 mL bags on allocation. Lactated ringer's with 5% dextrose 500 mL bags are on back order and the company cannot estimate a release date.

• BBraun has lactated ringer's injection solution and lactated ringer's with 5% dextrose injection solution products on allocation to current customers.

• ICU Medical has lactated ringer's 500 mL bags on back order and the company estimates a release date of late-May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=361 Furosemide Tablets May 16, 2018 Reason for the Shortage

• Major discontinued furosemide tablets in early-2018. • Mylan and Teva did not provide a reason for the shortage. • West-Ward states the shortage is due to manufacturing delays. • Sandoz discontinued furosemide tablets in late-August 2017.


• Mylan has furosemide 40 mg tablets in 100 count and 1000 count on back order and the company estimates a release date of early-June 2018.

• Teva has furosemide 20 mg and 40 mg tablets in 100 and 1000 count bottles temporarily unavailable and the company cannot estimate a release date.

• West-Ward has furosemide 20 mg tablets n 100 count and 1000 count bottles on allocation. The 40 mg tablets in 100 count and 1000 count bottles are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=339 Famotidine Injection May 16, 2018 Reason for the Shortage

• Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.[1] • West-Ward has famotidine vials available.[2]


• Pfizer launched famotidine injections in March 2012.[3] • Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013.[4] • Fresenius Kabi did not provide a reason for the shortage.[5] • Baxter has famotidine premixed bags available.[6]


• Fresenius Kabi has famotidine 4 mL vials on back order and the company estimates a release date of mid-May 2018.[5]

• Mylan Institutional has famotidine 2 mL, 4 mL, and 20 mL vials on back order and the company estimates a release date of late-July 2018 for the 2 mL vials, mid- to late-June 2018 for the 4 mL vials, and mid-July 2018 for the 20 mL vials.[4]

• West-Ward has famotidine 4 mL and 20 mL vials on back order and the company estimates a release date of June 2018. The 2 mL vials are on allocation.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=166 Dexpanthenol Injection May 16, 2018 Reason for the Shortage

• American Regent has dexpanthenol injection on shortage due to manufacturing delays. • There are no other suppliers of dexpanthenol injection.


• American Regent has dexpanthenol injection 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=65 Ceftriaxone Sodium Injection May 16, 2018 Reason for the Shortage

• Apotex states the reason for the shortage is manufacturing delays. Apotex launched several products with new NDC numbers in June 2017.

• Fresenius Kabi states the reason for the shortage is increased demand. • Pfizer has some ceftriaxone presentations available and did not provide a reason for the back order

of some presentations. • Sagent states the reason for the shortage is manufacturing delay. • Sandoz has most ceftriaxone presentations available. • West-Ward states the reason for the shortage is manufacturing delay. • Wockhardt relaunched their ceftriaxone presentations in October 2017.


• Apotex has ceftriaxone presentations on intermittent back order and the company is releasing supplies as they become available.

• Fresenius Kabi has ceftriaxone 2 gram vials available with a short expiration date (< 9 months). • Lupin has all ceftriaxone presentations on allocation. • Pfizer has ceftriaxone 500 mg vials, 1 gram ADD-Vantage vials, 2 gram vials, and 2 gram ADD-Vantage

vials on allocation.


• Sagent has ceftriaxone 2 gram vials on back order and the company estimates a release date in May 2018. The 1 gram vials are also on back order and the company estimates a release date in June 2018.

• Wockhardt has all ceftriaxone presentations on back order and the company cannot estimate a release date.

• West-Ward has ceftriaxone 500 mg vials on back order and the company cannot estimate a release date. The 2 gram vials are also on back order and the company estimates a release date in late-May to mid-June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=86 Bupivacaine Injection May 16, 2018 Reason for the Shortage

• 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. Estimated Resupply Dates

• 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 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of late-June 2018 for the 10 mL vials and mid-May 2018 for the 30 mL vials. The 0.25% 50 mL vials are on back order and the company estimates a release date of mid- to late-June 2018. The 0.5% Sensorcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of mid-June 2018 for the 10 mL vials and mid- to late-June 2018 for the 30 mL vials. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of early-June 2018. The 0.75% Sensorcaine 10 mL preservative-free vials are on back order and the company estimates a release date of late-May 2018. The 0.25% and 0.5% Sensorcaine 30 mL preservative-free vials in sterile packs are on back order and the company cannot estimate a release date.

• Pfizer has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of June 2018. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates a release date of June 2018. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of June 2018 for the 10 mL vials and May 2018 for the 30 mL vials. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of July 2018. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of June 2018 for the 10 mL vials and July 2018 for the 30 mL vials. The bupivacaine 0.75% in 8.25% dextrose 2 mL ampules are available in limited supply.

• Pfizer has all Marcaine presentations on back order and the company estimates a release date of March 2019 except for the bupivacaine 0.75% in 8.25% dextrose 2 mL ampules are on back order with an estimated release date of July 2018.

• Baxter has bupivacaine 0.75% in 8.25% dextrose 2 mL ampules on back order and the company estimates a release date of late-May 2018.



5% Dextrose Injection (Pvc-Free and Dehp-Free) May 16, 2018 Reason for the Shortage

• ICU Medical states the shortage is due to increased demand and manufacturing delays. ICU Medical discontinued the 500 mL VisIV bags in 2011 due to leaking around the administration and medications ports.

• ICU Medical is now the IV fluid business of Pfizer after the acquisition of Hospira. • Baxter is not currently marketing 5% dextrose PVC/DEHP-free bags. • BBraun has 250 mL, 500 mL, and 1,000 mL PVC/DEHP-free bags on back order due to manufacturing

delays. Estimated Resupply Dates

• BBraun has 5% dextrose 250 mL, 500 mL, and 1,000 mL PVC/DEHP-free bags on allocation to current customers.

• ICU Medical has 5% dextrose in 50 mL PVC/DEHP-free bags on back order and the company estimates a release date in late-May 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=314 0.9% Sodium Chloride Large Volume Bags May 16, 2018 Reason for the Shortage

• Baxter discontinued 0.9% sodium chloride 250 mL and 500 mL AVIVA bags. The Viaflex bags and Viaflo bags are on allocation.[1]

• BBraun did not provide a reason for the shortage.[2] • ICU Medical cited increased demand as the reason for the shortage.[3] • Fresenius Kabi is no longer importing product.[8] • Baxter has received FDA approval for 0.9% sodium chloride in Viaflo containers manufactured in an

FDA-approved facility in Spain. Additional information about this product is available at: http://www.baxter.com/information/saline_supply.html.


• Baxter has all 0.9% sodium chloride presentations on allocation.[1] • BBraun has 0.9% sodium chloride 250 mL, 500 mL, and 1,000 mL PVC/DEHP-free bags on allocation

to current customers.[2] • ICU Medical has 0.9% sodium chloride 250 mL, 500 mL, 1000 mL, and 500 mL bags with 2 ports are

on allocation.[3] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=76 Recombinant Zoster Vaccine (Shingrix) May 17, 2018 Reason for the Shortage

• GlaxoSmithKline has Shingrix on shortage due to high demand for the product.


Estimated Resupply Dates • GlaxoSmithKline has Shingrix kits in 1 count and 10 count on intermittent back order with regular

releases. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=427 Ondansetron Hydrochloride Injection May 17, 2018 Reason for the Shortage

• Apotex did not provide a reason for the shortage. • Athenex has ondansetron injection on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has ondansetron injection available. • Heritage has ondansetron on shortage due to increased demand. • Mylan Institutional did not provide a reason for the shortage. • Pfizer has ondansetron injection on shortage due to manufacturing delays. • Sagent has ondansetron injection on shortage due to manufacturing delays. • West-Ward did not provide a reason for the shortage. • Novartis discontinued Zofran 20 mL vials in May 2018.


• Apotex has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a release date of late-May 2018.

• Athenex has ondansetron 2 mg/mL 2 mL and 20 mL vials on back order and the company cannot estimate a release date.

• AuroMedics has ondansetron 2 mg/mL 2 mL and 20 mL vials on intermittent back order and the company is releasing product as it becomes available.

• Fresenius Kabi has ondansetron 2 mg/mL 2 mL vials on back order and the company cannot estimate a release date. The 2 mg/mL 2 mL prefilled syringes are on back order and the company estimates a release date of mid- to late-June 2018.

• Heritage has all ondansetron presentations on allocation. • Mylan Institutional has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a

release date of late-June 2018. The 20 mL vials are on back order and the company cannot estimate a release date.

• Pfizer has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a release date of May 2018. The 2 mg/mL 20 mL vials are available in limited supply. The 2 mg/mL 2 mL iSecure syringes are on back order and the company estimates a release date of 2019.

• Sagent has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a release date of July 2018.

• West-Ward has ondansetron 2 mg/mL 2 mL vials on allocation. The 2 mg/mL 20 mL 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=405 Lidocaine With Epinephrine Injection May 17, 2018 Reason for the Shortage

• 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

• Pfizer has 0.5% lidocaine with epinephrine (1:200,000) 50 mL vials on back order and the company estimates a release date of July 2018. The 1% lidocaine with epinephrine (1:100,000) 20 mL vials are on back order and the company estimates a release date of June 2018. The 1% lidocaine with epinephrine (1:100,000) 30 mL and 50 mL vials are on back order and the company estimates a release date of May 2018. The 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates a release date of September 2018. The 2% lidocaine with epinephrine (1:100,000) 20 mL, 30 mL, and 50 mL vials are on back order and the company estimates a release date of June 2018 for the 20 mL and 30 mL vials and July 2018 for the 50 mL vials.

• Fresenius Kabi has 0.5% Xylocaine with epinephrine (1:200,000) 50 mL vials on back order and the company cannot estimate a release date. The 1% Xylocaine with epinephrine (1:200,000) 10 mL vials are on back order and the company cannot estimate a release date. The 1% Xylocaine with epinephrine (1:200,000) 20 mL and 50 mL vials are on back order and the company estimates a release date of mid-May 2018 for the 20 mL vials and late-May 2018 for the 50 mL vials. The 1% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company cannot estimate a release date. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates a release date of late-May 2018. 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 1.5% Xylocaine-MPF with epinephrine (1:200,000) 10 mL regular vials and 30 mL vials 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 and the company estimates a release date of late-May 2018. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates a release date of mid-June 2018. The 2% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials and 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98 Ketorolac Injection May 17, 2018 Reason for the Shortage

• Alvogen has ketorolac injection available in 25 count sizes.[1] • Amphastar did not provide a reason for the shortage.[2] • Athenex has ketorolac injection available.[3] • BD RX is now part of Fresenius Kabi.[4] • Fresenius Kabi did not provide a reason for the shortage.[5] • Pfizer has ketorolac injection on back order due to manufacturing delays.[6] • Sagent states the reason for the shortage is manufacturing delay.[7] • West-Ward did not provide a reason for the shortage.[8] • Ben Venue closed its plant in Bedford, Ohio in July 2014.[9] • Virtus has ketorolac injection available.[10] • FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac.[11] • Sprix Nasal Spray is not affected by this shortage.[12]



• Alvogen has 15 mg/mL 1 mL vials and 30 mg/mL 1 mL vials on back order with unknown release dates.1

• Amphastar has ketorolac 30 mg/mL 1 mL vials on back order and the company cannot estimate a release date.[2]

• Fresenius Kabi has ketorolac 30 mg/mL 1 mL vials on back order and the company estimates a release date of late-May 2018.[5]

• Pfizer has ketorolac 15 mg/mL 1 mL vials and 30 mg/mL 1 mL vials on back order and the company estimates a release date in May 2018. The 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 are on back order and the company estimates a release date of 2019.[6]

• Sagent has all ketorolac products on back order. The company estimates release dates of July 2018 for the 30 mg/mL 2 mL vials for intramuscular injection, May 2018 for the 15 mg/mL 1 mL vials, and June 2018 for the 30 mg/mL 1 mL vials.[7]

• West-Ward has ketorolac 15 mg/mL 1 mL vials, 30 mg/mL 1 mL vials, and 30 mg/mL 2 mL vials for intramuscular injection on allocation.[8]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=113 Amiodarone Injection May 17, 2018 Reason for the Shortage

• Baxter has Nexterone premixed bags on shortage due to manufacturing delays. • Mylan Institutional did not provide a reason for the shortage. • West-Ward did not provide a reason for the shortage.


• Mylan Institutional has amiodarone 50 mg/mL 9 mL vials available that expire February 28, 2019. Amiodarone 50 mg/mL 3 mL and 18 mL vials are on back order and the company estimates a release date of late-May 2018 for the 3 mL vials and early-June 2018 for the 18 mL vials.

• Fresenius Kabi has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date of mid-May 2018.

• Baxter has Nexterone 150 mg/100 mL and 360 mg/200 mL premixes 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 Vecuronium Bromide Injection May 21, 2018 Reason for the Shortage

• Pfizer has vecuronium on shortage due to manufacturing delays.[1-2] • Teva has vecuronium on allocation due to increased demand.[3] • Pfizer sold vecuronium injection to Mylan Institutional in December 2013.[4-5] • Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.[6] • Sun Pharma has vecuronium available.[7] • Sagent is not marketing vecuronium 10 mg and 20 mg vials.[8] • Fresenius Kabi has vecuronium on shortage due to manufacturing delays.[9]



• Fresenius Kabi has vecuronium 10 mg vials on back order and the company estimates a release date of early-June 2018.[9]

• Mylan Institutional has vecuronium 20 mg vials on back order with an estimated release date of late-October to early-November 2018.[5]

• Pfizer has vecuronium 10 mg and 20 mg vials on back order and the company estimates a release date of 2019.[2]

• Teva has vecuronium 10 mg vials on allocation.[3] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=167 Phenytoin Sodium May 21, 2018 Reason for the Shortage

• West-Ward did not provide a reason for this shortage. • X-Gen Pharmaceuticals discontinued their phenytoin sodium presentations in April 2017.


• West-Ward has phenytoin sodium 100 mg/2 mL vials on back order and the company estimates a release date of late-May 2018. The 250 mg/5 mL vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=406 Diazepam Injection May 21, 2018 Reason for the Shortage

• Pfizer has diazepam on shortage due manufacturing delays. Estimated Resupply Dates

• Pfizer has diazepam 5 mg/mL 2 mL Carpuject syringes on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=330 Cefuroxime Sodium Injection May 21, 2018 Reason for the Shortage

• Sagent has cefuroxime injection on shortage due to manufacturing delays. • Teligent discontinued all Zinacef presentations in February 2018. • West-Ward did not provide a reason for the cefuroxime injection shortage.


• Sagent has cefuroxime 750 mg vials on back order and the company estimates a release date of June 2018.

• West-Ward has cefuroxime 750 mg vials on back order and the company cannot estimate a release date. The 7.5 gram vials are on back order and the company estimates a release date of June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=13 Calcium Chloride Injection


May 21, 2018 Reason for the Shortage

• American Regent has calcium chloride injection available. • Amphastar has calcium chloride injection available. • 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. Estimated Resupply Dates

• 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 June 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48 Caffeine and Sodium Benzoate Injection May 21, 2018 Reason for the Shortage

• American Regent has caffeine and sodium benzoate on shortage due to manufacturing delays. Estimated Resupply Dates

• American Regent has caffeine and sodium benzoate injection available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=385 *Please refer to ASHP website for more information at: http://www.ashp.org/menu/DrugShortages/CurrentShortages/

drug information update · 2018-05-29 · novartis today announced the us food and drug...

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