Recall D-0366-2022
Description: Metformin 750 mg Extended Release NDC # 70518-2920-00
Recall D-0366-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0366-2022 |
| Event ID | 89331 |
| Distribution | Product was distributed to one direct account in PA. |
| Quantity | 56 Blister Cards |
| Recall Reason | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. |
| Drug Classification | Class II |
| Drug Code Info | 20220119 |
| Recall Initiation Date | 20211230 |
| Report Date | 20220119 |
| Classification Date | 20220111 |
| Address | 625 Kolter Dr Ste 4 Indiana, PA 15701-3571 United States |
| Recalling Firm | RemedyRepack Inc. |
| Initial Notification | Letter |
| Similar To |