Drug recalls
627 recallsErythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations;
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oa…
Wisconsin Pharmacal Company
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 singl…
UCB Biosciences Inc.
Lack of Assurance of Sterility
Primidone Tablets, USP, 250 mg
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets USP, 250mg, 100-count bottle, Rx only
Lannett Company Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
fentaNYL Citrate, Sterile CADD for Injection, 2
IntegraDose Compounding Services LLC
Subpotent Drug
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Oasis Tears PF, Preservative-Free Lubricant Eye Drops
Oasis Medical, Inc.
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution foll…
Buprenorphine Hydrochloride, Injection, 0.3mg/mL
ENDO USA, Inc.
Crystallization;
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tab…
Ascend Laboratories, LLC
Failed Dissolution Specifications
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only
Acella Pharmaceuticals, LLC
Chemical contamination;
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with…
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s…
Fresenius Medical Care Holdings, Inc.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only
JB Chemicals and Pharmaceuticals Ltd
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impu…
Octreotide Acetate for Injectable Suspension
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food…
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp…
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp…
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only
Unichem Pharmaceuticals USA Inc.
Subpotent drug
TPN bag (patient specific), Rx# 11-4909703-0-1
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Incorrect Product Formulation: product did not contain insulin as listed in the label.
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with…
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only
Breckenridge Pharmaceutical, Inc.
CGMP Deviations;
Lactated Ringer's Injection USP, 1000 mL container, Rx only
B BRAUN MEDICAL INC
Presence of Particulate Matter.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s…
Fresenius Medical Care Holdings, Inc.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp…
fentaNYL Citrate Injectable Solution, Narcotic, CII
Wells Pharma of Houston LLC
cGMP deviations.
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz)
Alcon Research LLC
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr…
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Wells Pharma of Houston LLC
cGMP deviations.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
Wells Pharma of Houston LLC
cGMP deviations.
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii
Wells Pharma of Houston LLC
cGMP deviations.
Lidocaine Wound Gel (Benzalkonium Chloride
Water-Jel Technologies, LLC
Failed PH Specifications