Drug recall D-0533-2025
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
Reason for recall
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Lots and codes
Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
Recall details
- Recalling firm
- Ascend Laboratories, LLC, Bedminster, NJ
- Quantity
- N/A
- Distribution
- US Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 9, 2025
Related products
- Rizatriptan Benzoate – drug information
- NDC 67877-261 Rizatriptan Benzoate · Rizatriptan Benzoate 5 mg/1 · Ascend Laboratories, LLC
- NDC 67877-262 Rizatriptan Benzoate · Rizatriptan Benzoate 10 mg/1 · Ascend Laboratories, LLC