DEXAMETHASONE Recall D-1102-2022
Description: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36
DEXAMETHASONE Recall D-1102-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1102-2022 |
| Event ID | 89646 |
| Brand | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE |
| Generic Name | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE |
| Manufacturer | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE |
| Original Package? | 1 |
| Active Substance | DEXAMETHASONE NEOMYCIN SULFATE |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 120 tubes |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 61314-631 |
| Product NUI | N0000175576 N0000175450 |
| Drug UPC | 0361314631367 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| 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 057Y626693 |
| Drug Application Number | NDA050065 |
| Structured Product Labeling (SPL ID) | a3406db4-cee5-43b3-b9c1-63d01dccb2f7 |
| Structured Product Labeling (SPL Set ID) | 7f2e3c46-9f39-45e7-99a9-64cc4f6f649d |
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