Drug 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
D-0533-2025
Product summary
- Event
- Event 96770
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0533-2025
Official wording
Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Code information: Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-dimethyl-rizatriptan impurity
-
Manufacturing or process control
CGMP Deviations