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Recall Observatory FDA recall evidence

Drug product

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.

D-0660-2024

August 30, 2024

Class II

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 95279
Status
Completed
Classification
Class II
Quantity
2,031,480 ointments
Official record key
drug-enforcement:D-0660-2024

Official wording

Reason: Subpotent Drug

Code information: 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.

Distribution pattern: Product was distributed nationwide within the United States.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent