Product Safety Recalls and Alerts

The information contained in this section involves recalls and alerts issued regarding animal health products including vaccines, drugs (as well as human drugs that may be used in animals in accordance with the Animal Medicinal Drug Use Clarification Act – AMDUCA), and medical devices used by veterinarians.

This information is based on statements or press releases brought to the AVMA's attention by the manufacturer or the governmental agency (e.g., Food and Drug Administration, U.S. Department of Agriculture, Environmental Protection Agency) responsible for regulation of the products. If you are notified of a recall or alert that is not on this list, please email us to let us know.

For information about pet/animal food recalls (including pet, livestock, wild bird, and other animal feeds), visit our Pet Food Safety Recalls and Alerts page.

For information about reporting an adverse event associated with an animal health product, medical device, or animal feed product, visit our Reporting Adverse Events page.
Brand/Company
Product
Reason
Lot Code
Date
HospiraHydromorphone HCL injection, USP - CII, High-Potency Formulation (10 mg/ml)Glass vials may be empty or crackedNDC: 0409-2634-01
Lot #71330DD & expiration 1NOV2018; distributed in carton of 10 x 1mL single-dose vials		3/6/18
Hospira (distributed by Teva)Hydromorphone HCL injection, USP - CII, High-Potency Formulation (10 mg/ml)Glass vials may be empty or crackedVial NDC is 0703-0110-01 and carton NDC is 0703-0110-033/6/18
Sagent PharmaceuticalsMethylprednisolone Sodium Succinate for injection, USP, 40mgElevated impurityClick on product name to left for complete list of recalled lots3/6/18
Sagent PharmaceuticalsMethylprednisolone Sodium Succinate for injection, USP,125mgElevated impurityClick on product name to left for complete list of recalled lots3/6/18
Sagent PharmaceuticalsMethylprednisolone Sodium Succinate for injection, USP, 1gElevated impurityClick on product name to left for complete list of recalled lots3/6/18
PharMEDium ServicesCompounded sterile products (expanded recall)Lack of sterility assuranceAll unexpired products compounded at PharMEDium's Memphis facility. Click on product name at left to identify affected products based on label photos. 1/11/18
International LaboratoriesClopidogrel tablets, USP 75 mgMislabeling - may contain either Clopidogrel or SimvastatinLot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets1/10/18
AuroMedics PharmaAmpicillin and Sulbactam for InjectionGlass particlesLot # AF0117001-A; expiration date December 2018; NDC: 55150-116-20; packaged in 10-vial carton1/9/18
AuroMedics PharmaLinezolid for injection, 600mg/300mL flexible bagsMoldNDC 55150-242-51, batch CLZ160007, with expiration August 201812/22/17
AuroMedics PharmaPantoprazole Sodium for injection, 40 Mg per vialGlass particles found in one vialNDC: 55150-202-10.  Lot #CPO170035 with exp. Date of May 2019.12/19/17
Sun Pharmaceutical Industries, Inc.Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mLMicrobial contamination which could potentially result in a risk of infection, especially in the immunocompromised patientNDC Code 10631-206-01, Lot A160031A, Exp.: 01/2018
NDC 10631-206-02, Lot: A160031B, Exp.: 01/2018		11/24/17
Greenstone LLCDiphenoxylate hydrochloride and atropine sulfate tablets, USPPotential to be super potent or sub potentMultiple lots affected; click on product name to left for complete list 11/16/17
Baxter International Inc.NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed InjectionPossible presence of particulate matterLot code: NC109925
Exp: 6/1/2019		11/14/17
Fresenius KabiMidazolam Injection, USP, 2 mg/2 mLMislabeled; reports that packages contain Ondansetron Injection Lot 6400048, expires July 201811/3/17
SCA PharmaceuticalsSuccinylcholine Chloride 20 mg/mL 10 mL syringePotential to contain microbial contamination20170726@3510/20/17
SCA PharmaceuticalsHydromorphone 1 mg/mL in 25 mL 0.9% Sodium ChloridePotential to contain microbial contamination20170808@5210/20/17
SCA PharmaceuticalsFentanyl 2 mcg/mL + Bupivacaine 0.125% in 250 mL 0.9% Sodium ChloridePotential to contain microbial contamination20170814@2010/20/17
SCA PharmaceuticalsHydromorphone 20 mcg/mL + Bupivacaine 0.075% in 50 mL 0.9% Sodium ChloridePotential to contain microbial contamination20170816@6510/20/17
SCA PharmaceuticalsMorphine 1 mg/mL in 50 mL 0.9% Sodium ChloridePotential to contain microbial contamination20170901@2510/20/17
SCA PharmaceuticalsMorphine 1 mg/mL in 100 mL 0.9% Sodium Chloride (CADD)Potential to contain microbial contamination20170905@2410/20/17
SCA PharmaceuticalsOxytocin 30 units added to 500 mL Lactated RingersPotential to contain microbial contamination20170912@1310/20/17
SCA PharmaceuticalsPhenylephrine 100 mcg/mL 10 mL in 12 mL syringePotential to contain microbial contamination20170920@5310/20/17
SCA PharmaceuticalsFentanyl 2 mcg/mL (as citrate) Ropivacaine HCl 0.1%Potential to contain microbial contamination20170815@2610/20/17
SCA PharmaceuticalsCalcium Gluconate 2 g added to 50 mL 0.9% Sodium ChloridePotential to contain microbial contamination20170920@2010/20/17
SCA PharmaceuticalsRocuronium 10 mg/mL 5 mL in 6 mL syringePotential to contain microbial contamination20171004@410/20/17
Baxter International Inc.Intralipid 20% IV fat emulsion, 100 mlProduct exposed to subfreezing temperaturesProduct code 2B6061 and lot #10LE9597, with exp. date of 4/1/2019 and NDC 0338-0519-5810/5/17
HospiraHydromorphone HCI injection USP, CII (2 mg/mL)Potential lack of sterility assurance2 mg/mL, 1 mL in 2 mL vial, with lot #760853A and expiration date 1APR20198/31/17
HospiraLevophed (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) vialsPotential lack of sterility assuranceClick on product name to left for complete list of lot numbers and expiration dates8/31/17
Atlantic Pharmacy & CompoundingAll compounded injectable prescription medicationsLack of sterility assuranceAll8/17/17
Amneal PharmaceuticalsLorazepam oral concentrate, USP 2mg/mLMisprinted dosing droppersClick on product name to left for complete list8/14/17
Rugby LaboratoriesRugby Laboratories recalls Diocto Liquid and Diocto Syrup (docusate sodium) due to possible contaminationPossible product contaminationDiocto Liquid 50 mg/5 mL NDC 0536-0590-85; or Diocto Syrup 60mg/15mL NDC 0536-1001-85. Consumers with questions regarding this recall should contact Rugby's Customer Support Department at 1-800-645-2158.8/2/17
ICU Medical Inc.0.9% Sodium Chloride InjectionPresence of particulate matterOne lot is affected: 1000mL single-dose flexible container with Lot #61-841-FW; NDC #0409-7983-09; and expiration date January 01, 2018.7/28/17
Apace Packaging LLCCyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15potential mislabelingLot Number 167107/27/17
Apace Packaging LLCAmantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15potential mislabelingLot Number 167107/27/17
Novo NordiskInsulin cartridge holders used in a small number of NovoPen Echo® batchesMay crack or break if exposed to certain chemicals, like certain cleaning agentsU.S. batch numbers:
- EVG1221
- EVG1226
- FVG7149
- FVG7458
- FVG8134
- FVG8135		7/5/17
PharMEDium ServicesPotassium phosphate and succinylcholine chloridePotential lack of sterility assuranceClick on product name to left for complete list6/26/17
Fagron Sterile ServicesSuccinylcholine chloride 20mg/mL 5mL syringepotential lack of sterility assuranceThree lots:
   - Lot C274-000000331 with beyond-use date of 08/30/2017
   - Lot C274-000001274 with beyond-use date of 09/07/2017
   - Lot C274-000001326 with beyond-use date of 09/14/2017		6/23/17
AlvogenClindamycin Injection USP ADD-Vantage Vials, Alvogenlack of sterility assuranceClick on product name to left for complete list6/16/17
Datascope Corp./MaquetIntra-aortic balloon pumps: System CS100, CS100i and CS300Potential electrical test failure codeThe specific pumps involved are:
- CS100i pump: Part #0998-UC-0446HXX
- CS100i pump: Part #0998-UC-0479HXX
- CS100 pump: Part #00998-00-3013-XX
- CS100 pump: Part #0998-UC-3013-XX
- CS300 pump: Part #00998-00-3023-XX
- CS300 pump: Part #0998-UC-3023-XX.

The recall also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP.		6/16/17
Hospira8.4% sodium bicarbonate injection; Neut (sodium bicarbonate 4% additive solution); Quelicin (succinylcholine chloride injection); potassium phosphates injectionPotential lack of sterility assuranceClick on product name to left for complete list6/15/17
Bristol-Myers SquibbEliquis® (apixaban) 5 mg TabletsPossible mis-labeling of product strengthA single lot (#HN0063) of Eliquis® 5 mg tablets is recalled to the retail/dispensing level only - not to the consumer level.6/10/17
C.O. Truxton, Inc.C.O. Truxton, Phenobarbital, USP 15mg 30mg, 60mg & 100mg TabletsPossible mis-labeling15mg tablets (1000) w/ NDC Code 0463-6160-10:
-Lot #70915A & expiration August 2017
-Lot #H15A55 & expiration November 2017
-Lot #70952A & expiration November 2017
-Lot #71162A & expiration October 2017

30mg tablets (1000) w/ NDC Code 0463-6145-10
-Lot #70926A & expiration November 2017
-Lot #70981A & expiration January 2018
-Lot #H15A59 & expiration August 2018

60mg tablets (1000) w/ NDC Code 0463-6151-10:
-Lot #70881A & expiration July 2017
-Lot #H15A68 & expiration January 2018
-Lot #70980A & expiration February 2018
-Lot #71416A & expiration May 2020

100mg tablets (100) w/ NDC Code 0463-6155-01:
-Lot #70989A & expiration February 2018
-Lot #70973A & expiration January 2018

100mg tablets (1000) w/ NDC Code 0163-6152-10:
-Lot #70973A & expiration January 2018
-Lot #H15A76 & expiration February 2018
-Lot #71346A & expiration December 2019
5/8/17
C.O. Truxton, Inc.C.O. Truxton, Amitriptyline HCL Tablets, USP 50mgPossible mis-labelingNDC Code 0463-6352-10, Lot #C0260416A & expiration of March 20185/8/17

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