Class II
Ongoing
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99
This recall is currently active, issued June 12, 2024. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- May 10, 2024
- Posted
- June 12, 2024
- Recall Number
- D-0532-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,480 cartons
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Distribution
US Nationwide.
Lot / Code Info
Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024
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