Class I - Dangerous
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class I - Dangerous
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class I - Dangerous
Failed Dissolution Specifications: low dissolution results
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class I - Dangerous
Subpotent drug
Class I - Dangerous
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class I - Dangerous
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class I - Dangerous
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Breckenridge Pharmaceutical
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Class I - Dangerous
Lack of Processing Controls.
Class I - Dangerous
Lack of Processing Controls.
Class I - Dangerous
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class I - Dangerous
Lack of Processing Controls.
Class I - Dangerous
Lack of Processing Controls.