Status
Ongoing
Drug Enforcement D-0534-2025
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Classification
Class II
Report Date
July 23, 2025
Termination Date
—
Product Information
- Product description
- Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- US Nationwide.
Location & Firm
- Recalling firm
- Ascend Laboratories, LLC
- Address
-
135 Us Highway 202 206 Ste 15, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0534-2025
- Event ID
- 96770
- Recall initiation date
- July 9, 2025
- Center classification date
- July 17, 2025
- Code info
- Lot 22143653, 22143675, Exp Date: July 2025; Lot 22144528, Exp Date: September 2025; Lot 22144977, Exp Date: November 2025; Lot 23140257, Exp Date: December 2025; Lot 23140999, Exp Date: Feb. 2026; Lot 23141900, 23142118, 23142120, 23142123, Exp Date: May 2026; Lot 23144563, 23144565, Exp Date: November 2026; Lot 24142623, Exp Date: May 2027; Lot 24142624, 24142626, 24143469, Exp Date: Jun. 2027.
- More code info
- —