Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Failed stability specifications: Out of specification for hardness test
Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Cross Contamination with Other Products
Class I - Dangerous
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
Park Avenue Compounding
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class I - Dangerous
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class I - Dangerous
Defective Container - A defect in the side-seal which allows leakage of product.
Class I - Dangerous
Failed Stability Specifications: Observed OOS results: eg results for colour index
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Fresenius Kabi USA
Class I - Dangerous
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Class I - Dangerous
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
Park Avenue Compounding
Class I - Dangerous
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Class I - Dangerous
Subpotent Drug
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
Alembic Pharmaceuticals Limited
Class I - Dangerous
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class I - Dangerous
Subpotent drug; Clavulanate Potassium component