POVIDONE-IODINE Recall D-1008-2022
Description: Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical Inc., NDC 0065-0411-30
POVIDONE-IODINE Recall D-1008-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1008-2022 |
| Event ID | 89646 |
| Brand | BETADINE |
| Generic Name | POVIDONE-IODINE |
| Manufacturer | POVIDONE-IODINE |
| Original Package? | 1 |
| Active Substance | POVIDONE-IODINE |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 799 cartons/1 bottle each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0065-0411 |
| Product NUI | N0000175486 M0011640 |
| Drug UPC | 0035410000074 |
| Pharma Class (EPC) | Antiseptic [EPC] |
| Pharma Class (CS) | Iodine [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 | 85H0HZU99M |
| Drug Application Number | NDA018634 |
| Structured Product Labeling (SPL ID) | 0fcbe927-f60a-4e9b-b83f-07b9b9ae871d |
| Structured Product Labeling (SPL Set ID) | b026de1b-9949-4557-ac49-c7b0038c24cd |
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