Recall D-0441-2023
Description: Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
Recall D-0441-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0441-2023 |
| Event ID | 91744 |
| Distribution | CA |
| Quantity | 12,044 Bottles |
| 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 | 20230315 |
| Recall Initiation Date | 20230222 |
| Report Date | 20230315 |
| Classification Date | 20230307 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA Inc |
| Initial Notification | Letter |
| Similar To |