FDA-Drug2024-06-12Class II
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
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Sold states
US Nationwide.
Affected count
2400 cartons
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0534-2024Don't want to check this manually?
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