Drug recall D-0532-2024
Product
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
Reason for recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Lots and codes
Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 3,480 cartons
- Distribution
- US Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 10, 2024
Related products
- Rizatriptan Benzoate – drug information
- NDC 68462-466 Rizatriptan benzoate · Rizatriptan Benzoate 10 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-465 Rizatriptan benzoate · Rizatriptan Benzoate 5 mg/1 · Glenmark Pharmaceuticals Inc., USA