Drug recalls
500 recalls0.9% Sodium Chloride Injection, USP
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%)
GE Healthcare Ireland Limited
Presence of particulate matter
Lanreotide Injection, 120 mg/0.5 mL
Cipla USA, Inc.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for…
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in…
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Clonidine Transdermal System, USP, 0.3 mg/day
Teva Pharmaceuticals USA, Inc
CGMP Deviations: use of an unapproved raw material
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Inje…
Fagron Compounding Services
Lack of Assurance of Sterility;
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL…
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in…
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Xanax XR, alprazolam, extended-release tablets, 3 mg
Viatris, Inc.
Failed Dissolution Specifications
Artificial Tears Lubricant Eye Drops (glycerin 0.2%
Preferred Pharmaceuticals, Inc.
Lack of Assurance of Sterility
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injec…
Fagron Compounding Services
Lack of Assurance of Sterility;
0.9% Sodium Chloride Injection
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs
Teva Pharmaceuticals USA, Inc
Superpotent and Subpotent
Vancomycin HCL, 1 gram added to 250 mL
Fagron Compounding Services
Lack of Assurance of Sterility;
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%)
GE Healthcare Ireland Limited
Presence of particulate matter
Isotretinoin Capsules, USP, 30 mg, Rx Only
Teva Pharmaceuticals USA, Inc
Superpotent and Subpotent
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL)
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lanreotide Injection, 120 mg*/0.5 mL
Cipla USA, Inc.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for…
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im…
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles
Amneal Pharmaceuticals, LLC
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was f…
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im…
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag
Amneal Pharmaceuticals, LLC
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actua…
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Ultra Lubricating Eye Drops (polyethylene 400 0.4%
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%)
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Dry Eye Relief Eye Drops, (glycerin 0.2%
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline…
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility