FDA Recall D-0535-2024

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 731 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot#: 19223402; Exp. 7/2024 Lot#: 19224858; Exp. 11/2024 Lot#: 19232492; Exp. 6/2025

Quantity: 13296 cartons

Reason for recall

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

Recall record

Recall number: D-0535-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2024-05-13
Classified by FDA Center: 2024-06-04
FDA published: 2024-06-12
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): RIZATRIPTAN BENZOATE
Generic name(s): RIZATRIPTAN BENZOATE
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-467, 68462-468
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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