Class II
Drug Recall: Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99
Glenmark Pharmaceuticals Inc., USA · May 10, 2024
Reason for Recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Distribution
US Nationwide.
States Affected
NATIONWIDE
Quantity Affected
3,480 cartons
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0532-2024
Status: ongoing
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