Product Safety Recalls

Product Recall Tracker

MUPIROCIN Recall D-1075-2022

Description: Mupirocin Ointment, USP 2%, 22 grams tube, Rx only, MFG: Teva Pharma USA, NDC 0093-1010-42, MFG: Teva Pharma USA

MUPIROCIN Recall D-1075-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1075-2022
Event ID89646
BrandMUPIROCIN
Generic NameMUPIROCIN
ManufacturerMUPIROCIN
Original Package?1
Active SubstanceMUPIROCIN
Drug RouteTOPICAL
DistributionUSA nationwide.
Quantity5 tubes
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0093-1010
Product NUIN0000175515 N0000175516
Pharma Class (EPC)RNA Synthetase Inhibitor Antibacterial [EPC]
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierD0GX863OA5
Drug Application NumberANDA065085
Structured Product Labeling (SPL ID)bcf7c316-879c-4c93-aee4-e45705bfc039
Structured Product Labeling (SPL Set ID)a543797a-2c1c-4ea3-bd6c-227a784f92d9
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