FDARecalled Jun 12, 2024 · #D-0533-2024
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
Hazard
Class II — temporary health risk
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CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. Classification: Class II Distribution: US Nationwide.
Product details
- Product
- Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
- Type
- Drugs
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Model numbers
- 19224217, 19233789, 19224444
- UPCs
- —