FDAFDA · Food and drugs·Recall number D-0534-2024
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
Published June 12, 2024 · Recall initiated: May 13, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- US Nationwide.
- UPC
- 0368462467060
- Lot
- Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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