DEXAMETHASONE Recall D-0995-2022
Description: TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
DEXAMETHASONE Recall D-0995-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0995-2022 |
| Event ID | 89646 |
| Brand | TOBRADEX |
| Generic Name | TOBRAMYCIN AND DEXAMETHASONE |
| Manufacturer | TOBRAMYCIN AND DEXAMETHASONE |
| Original Package? | 1 |
| Active Substance | DEXAMETHASONE TOBRAMYCIN |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 3 tubes |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0078-0876 |
| Product NUI | N0000175576 N0000175450 N0000175477 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Pharma Class (CS) | Aminoglycosides [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 | 7S5I7G3JQL VZ8RRZ51VK |
| Drug Application Number | NDA050616 |
| Structured Product Labeling (SPL ID) | d8137608-cc62-41a5-9d33-18df480e4152 |
| Structured Product Labeling (SPL Set ID) | 7f310e0e-0d3b-493d-b6c4-238493a2a9b9 |
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