Recall D-0994-2022
Description: Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20
Recall D-0994-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0994-2022 |
| Event ID | 89646 |
| Brand | MIOCHOL E |
| Generic Name | ACETYLCHOLINE CHLORIDE |
| Manufacturer | ACETYLCHOLINE CHLORIDE |
| Original Package? | 1 |
| Distribution | USA nationwide. |
| Quantity | 45 kits |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 24208-539 |
| Drug UPC | 0324208539200 |
| 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 |
| Drug Application Number | NDA020213 |
| Structured Product Labeling (SPL ID) | cce0408b-d981-4c18-b80b-d9e4d65ab15e |
| Structured Product Labeling (SPL Set ID) | e701ef07-9499-4b56-931f-f4eb3eedbe24 |
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