FDA Recall D-0639-2020

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 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60

Lot / code: 7701164A 7701471A 7701670B 7701827A 7702242A 7702705A 7702947A 7703408A 7704494A 7704495A 19190289 19190342 19190372 7702737A

Quantity: 208,668 bottles

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Recall record

Recall number: D-0639-2020
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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