FDA Recall D-0641-2020

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 2340 days on record

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

Product

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30

Lot / code: 7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490

Quantity: 98,988 bottles

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Recall record

Recall number: D-0641-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Natiowide
Recall initiated: 2019-12-17
Classified by FDA Center: 2020-01-05
FDA published: 2020-01-15
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

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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