← FDA ENFORCEMENT
D-0534-2024Class II

Glenmark Pharmaceuticals Inc., USA

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product type
Drug
Status
Ongoing
Report date
2024-06-12
Distribution
US Nationwide.
Firm state
NJ
Product quantity
2400 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.