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D-0660-2024Class II

Glenmark Pharmaceuticals Inc., USA

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product type
Drug
Status
Completed
Report date
2024-10-02
Distribution
Product was distributed nationwide within the United States.
Firm state
NJ
Product quantity
2,031,480 ointments
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent Drug

Product description

Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22.

Code / lot info

Lot #: 19223615, 19223537, 19223544,19223568, 19223593,19223641, Exp. Date 08/2024; 19224055,19224281, 19224307, 19224321, 19224341, 19224467, Exp. Date 09/2024; 19224525, 19224542, 19224560,19224580, Exp. Date 10/2024; 19224990, 19224998, 19225014, 19225033, 19225293, 19225304, 19225320, 19225349, 19225367, 19225379, 19225401, Exp. Date 11/2024; 19230115, 19230123, 19230132, 19230137, 19230167, 19230170, Exp. Date 12/2024; 19230572, 19230607, 19230614, 19230628, 19230631, Exp. Date 1/2025; 19230874, 19230925,19230941, 19230957, 19230976,19231232, 19231238, 19231282,19231285, Exp. Date 02/2025.

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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.