Recalls / Class II
Class IID-0534-2024
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
- Brand name
- Rizatriptan Benzoate
- Generic name
- Rizatriptan Benzoate
- Active ingredient
- Rizatriptan Benzoate
- Route
- Oral
- NDCs
- 68462-467, 68462-468
- FDA application
- ANDA201914
- Affected lot / code info
- Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025
Why it was recalled
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 2400 cartons
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2024-05-13
- FDA classified
- 2024-06-04
- Posted by FDA
- 2024-06-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0534-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.