FDAMay 13, 2024drug

Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

What to do

FDA enforcement status: Ongoing

Brands named

glenmark pharmaceuticalsglenmark

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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