Out-of-specification test results obtained for identification testing based on HPTLC analysis.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99
Aurobindo Pharma USA
Class I - Dangerous
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
The Harvard Drug Group
Class I - Dangerous
Failed Dissolution Specifications
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
American Health Packaging
Class I - Dangerous
Failed Impurities/Degradation Specifications
Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
Morton Grove Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class I - Dangerous
Subpotency: one product for active ingredient assay and another one for preservative assay
Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Subpotency: one product for active ingredient assay and another one for preservative assay
Class I - Dangerous
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class I - Dangerous
Lack of Assurance of Sterility