Drug recalls
627 recallsIsotretinoin 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;
Clonidine Transdermal System, USP, 0.3 mg/day
Teva Pharmaceuticals USA, Inc
CGMP Deviations: use of an unapproved raw material
0.9% Sodium Chloride Injection
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Vancomycin HCI, 1.5 grams added to 250 mL
Fagron Compounding Services
Lack of Assurance of Sterility;
Xanax XR, alprazolam, extended-release tablets, 3 mg
Viatris, Inc.
Failed Dissolution Specifications
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Vancomycin HCI, 1.25 grams added to 250 mL
Fagron Compounding Services
Lack of Assurance of Sterility;
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
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
0.9% Sodium Chloride Injection, USP
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…
Clonidine Transdermal System, USP, 0.1 mg/day
Teva Pharmaceuticals USA, Inc
CGMP Deviations: use of an unapproved raw material
0.9% Sodium Chloride Injection, USP
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
0.45% Sodium Chloride Injection, USP
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP
Fresenius Kabi USA, LLC
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, (4
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%)
GE Healthcare Ireland Limited
Presence of particulate matter
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…
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Inje…
Fagron Compounding Services
Lack of Assurance of Sterility;
0.9% Sodium Chloride Injection, USP, (2
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Artificial Tears Lubricant Eye Drops (glycerin 0.2%
Preferred Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Isotretinoin Capsules, USP, 30 mg, Rx Only
Teva Pharmaceuticals USA, Inc
Superpotent and Subpotent
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%)
GE Healthcare Ireland Limited
Presence of particulate matter
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