FDAFDA · Food and drugs·Recall number D-0533-2024
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
Published June 12, 2024 · Recall initiated: May 10, 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
- 0368462465998
- Lot
- Lot#: 19224217; Exp. 9/2024 Lot#: 19233789; Exp. 9/2025 Lot#: 19224444; Exp. 9/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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