FDAHealthJuly 9, 2025
Ascend Laboratories, LLC — Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsi
⚠️ CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 9, 2025
US Nationwide.
What's affected?
- 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
- Brand
- RIZATRIPTAN BENZOATE
- UPC
- 0367877261300
- Lot code
- 23142117
Additional details
Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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