Class II

Drug Recall: 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 · May 13, 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

2400 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0534-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.