Failed stability specifications: Out of specification for hardness test
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Prescription Drugs
💊 Drugs • 11,927 recalls
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Dr. Reddy's Laboratories
Class I - Dangerous
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Winder Laboratories
Class I - Dangerous
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class I - Dangerous
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Lupin Pharmaceuticals
Class I - Dangerous
Defective container - seal not adhering to bottles
Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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