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Recall Enforment Report D-0534-2024

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Glenmark Pharmaceuticals Inc., USA, originally initiated on 05-13-2024 for the product Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06 The product was recalled due to cgmp deviations: n-nitroso desmethyl rizatriptan impurity results that are above the fda acceptable limit.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0534-202405-13-202406-12-2024Class II2400 cartonsRizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.Ongoing
D-0535-202405-13-202406-12-2024Class II13296 cartonsRizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68462-467Rizatriptan Benzoate Rizatriptan BenzoateTablet, Orally DisintegratingOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-468Rizatriptan Benzoate Rizatriptan BenzoateTablet, Orally DisintegratingOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug