Class II
Ongoing
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
- Recall Initiated
- May 13, 2024
- Posted
- June 12, 2024
- Recall Number
- D-0534-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2400 cartons
- Firm Location
- Mahwah, NJ, United States
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#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025
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