Drug product
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
D-0533-2024
Product summary
- Event
- Event 94606
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,976 cartons
- Official record key
drug-enforcement:D-0533-2024
Official wording
Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Code information: Lot#: 19224217; Exp. 9/2024 Lot#: 19233789; Exp. 9/2025 Lot#: 19224444; Exp. 9/2024
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso Desmethyl Rizatriptan Impurity
-
Manufacturing or process control
CGMP Deviations