IBUPROFEN Recall D-1055-2022
Description: Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61
IBUPROFEN Recall D-1055-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1055-2022 |
| Event ID | 89646 |
| Brand | IBUPROFEN |
| Generic Name | IBUPROFEN |
| Manufacturer | IBUPROFEN |
| Active Substance | IBUPROFEN |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 1 carton/100 blisters per carton |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0904-5853 0904-5854 0904-5855 |
| Product NUI | N0000000160 M0001335 N0000175722 |
| Pharma Class (EPC) | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Pharma Class (CS) | Anti-Inflammatory Agents, Non-Steroidal [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 | WK2XYI10QM |
| Drug Application Number | ANDA075682 |
| Structured Product Labeling (SPL ID) | 84f91e64-4b87-4289-b004-150f5b173290 |
| Structured Product Labeling (SPL Set ID) | ba86e936-ef72-43e5-aebf-f2c788fe2266 |
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