Drug product
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06
D-0534-2024
Product summary
- Event
- Event 94608
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2400 cartons
- Official record key
drug-enforcement:D-0534-2024
Official wording
Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Code information: Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso Desmethyl Rizatriptan Impurity
-
Manufacturing or process control
CGMP Deviations