LEVOFLOXACIN Recall D-1088-2022
Description: Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61
LEVOFLOXACIN Recall D-1088-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1088-2022 |
| Event ID | 89646 |
| Brand | LEVOFLOXACIN |
| Generic Name | LEVOFLOXACIN |
| Manufacturer | LEVOFLOXACIN |
| Active Substance | LEVOFLOXACIN |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 1 box/100 blisters packs per box |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0904-6351 0904-6352 0904-6353 |
| Product NUI | N0000175937 M0023650 |
| Pharma Class (EPC) | Quinolone Antimicrobial [EPC] |
| Pharma Class (CS) | Quinolones [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 | 6GNT3Y5LMF |
| Drug Application Number | ANDA076710 |
| Structured Product Labeling (SPL ID) | fd353596-a7b5-4720-83fb-b21c6bb481eb |
| Structured Product Labeling (SPL Set ID) | ac4001ca-882f-4d9b-a570-c1b9d7fd6830 |
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