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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1075-2022 |
| Event ID | 89646 |
| Brand | MUPIROCIN |
| Generic Name | MUPIROCIN |
| Manufacturer | MUPIROCIN |
| Original Package? | 1 |
| Active Substance | MUPIROCIN |
| Drug Route | TOPICAL |
| Distribution | USA nationwide. |
| Quantity | 5 tubes |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0093-1010 |
| Product NUI | N0000175515 N0000175516 |
| Pharma Class (EPC) | RNA Synthetase Inhibitor Antibacterial [EPC] |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | D0GX863OA5 |
| Drug Application Number | ANDA065085 |
| 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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