SULFAMETHOXAZOLE Recall D-1059-2022
Description: Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-2725-61
SULFAMETHOXAZOLE Recall D-1059-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1059-2022 |
| Event ID | 89646 |
| Brand | SULFAMETHOXAZOLE AND TRIMETHOPRIM |
| Generic Name | SULFAMETHOXAZOLE AND TRIMETHOPRIM |
| Manufacturer | SULFAMETHOXAZOLE AND TRIMETHOPRIM |
| Active Substance | SULFAMETHOXAZOLE TRIMETHOPRIM |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 32 cartons/100 blister packs per carton |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0904-2725 |
| Product NUI | N0000175504 M0020790 N0000185504 |
| Pharma Class (EPC) | Sulfonamide Antimicrobial [EPC] |
| Pharma Class (CS) | Sulfonamides [CS] |
| 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 | JE42381TNV AN164J8Y0X |
| Drug Application Number | ANDA076899 |
| Structured Product Labeling (SPL ID) | ab6c95db-cd6d-4646-830a-d8474ccb3a2a |
| Structured Product Labeling (SPL Set ID) | abe0d2d5-4879-4b4e-9b57-47ea83a17ba0 |
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