METRONIDAZOLE Recall D-1048-2022
Description: Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87
METRONIDAZOLE Recall D-1048-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1048-2022 |
| Event ID | 89646 |
| Brand | METRONIDAZOLE |
| Generic Name | METRONIDAZOLE |
| Manufacturer | METRONIDAZOLE |
| Original Package? | 1 |
| Active Substance | METRONIDAZOLE |
| Drug Route | VAGINAL |
| Distribution | USA nationwide. |
| Quantity | 7 tubes |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0781-7077 |
| 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 | ANDA077264 |
| Structured Product Labeling (SPL ID) | a00b814a-ba5f-4af8-b50d-fa231339148b |
| Structured Product Labeling (SPL Set ID) | 0030514f-879d-416d-b422-24b67e334b36 |
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