OFLOXACIN Recall D-1114-2022
Description: Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3
OFLOXACIN Recall D-1114-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1114-2022 |
| Event ID | 89646 |
| Brand | OFLOXACIN |
| Generic Name | OFLOXACIN OTIC |
| Manufacturer | OFLOXACIN OTIC |
| Original Package? | 1 |
| Active Substance | OFLOXACIN |
| Drug Route | AURICULAR (OTIC) |
| Distribution | USA nationwide. |
| Quantity | 1 carton |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 69238-1615 69238-1616 |
| Product NUI | N0000175937 M0023650 |
| Drug UPC | 0369238161533 0369238161663 |
| 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 | A4P49JAZ9H |
| Drug Application Number | ANDA211525 |
| Structured Product Labeling (SPL ID) | a12ac48b-c86d-4a98-8515-c3114badff4b |
| Structured Product Labeling (SPL Set ID) | ba37e2a0-1bf7-41ca-bddd-35fcb77f87de |
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