METRONIDAZOLE Recall D-1056-2022
Description: Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-1453-61
METRONIDAZOLE Recall D-1056-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1056-2022 |
| Event ID | 89646 |
| Brand | METRONIDAZOLE |
| Generic Name | METRONIDAZOLE |
| Manufacturer | METRONIDAZOLE |
| Active Substance | METRONIDAZOLE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 3 boxes/100 blisters per box |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0904-1453 |
| Product NUI | N0000175435 M0014907 |
| Pharma Class (EPC) | Nitroimidazole Antimicrobial [EPC] |
| Pharma Class (CS) | Nitroimidazoles [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 | 140QMO216E |
| Drug Application Number | ANDA070027 |
| Structured Product Labeling (SPL ID) | 78277efb-75b2-49e1-afc6-cdc452eebe87 |
| Structured Product Labeling (SPL Set ID) | efb2f572-1e11-43e3-a653-eaeafc17ec79 |
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