D-0533-2025 Class II Ongoing
FDA drug recall D-0533-2025 was initiated by Ascend Laboratories, LLC on July 9, 2025 and is designated Class II. Reason for recall: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- July 23, 2025
- Initiation Date
- July 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
Distribution Pattern
US Nationwide.
Code Information
Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027