FDARecalled Jul 23, 2025 · #D-0533-2025
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 678...
Hazard
Class II — temporary health risk
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CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. Classification: Class II Distribution: US Nationwide.
Product details
- Product
- Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
- Type
- Drugs
- Manufacturer
- Ascend Laboratories, LLC
- Model numbers
- 23142117, 24142625
- UPCs
- —