Class I - Dangerous
Subpotent Drug: Assay below the approved specification
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Subpotent Drug: Assay below the approved specification
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class I - Dangerous
Subpotent Drug: Assay below the approved specification
Class I - Dangerous
cGMP deviations
Class I - Dangerous
cGMP deviations
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
Macleods Pharmaceuticals
Class I - Dangerous
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Breckenridge Pharmaceutical
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
cGMP deviations
Class I - Dangerous
cGMP deviations
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Class I - Dangerous
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Class I - Dangerous
Failed Impurity/Degradation Specifications
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.
Orient Pharma Co., Ltd. Yunlin Plant
Class I - Dangerous
Failed Impurities/Degradation Specifications.
Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class I - Dangerous
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.