Mupirocin Ointment
FDA Recall NDC 68462-180
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mupirocin (NDC 68462-180). A significant event, classified as Class II, was initiated on Aug 30, 2024 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Subpotent Drug"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Subpotent Drug
Aug 30, 2024
Oct 02, 2024
2,031,480 ointments
Recall Profile & Regulatory Data
Event ID
95279
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide within the United States.
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.
Batch or Lot Expiration 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.
Affected Packages Involved in this Recall
68462-180-22Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
