Recall D-0217-2025
Description: Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
Recall D-0217-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0217-2025 |
| Event ID | 96191 |
| Distribution | FL |
| Quantity | 247 blister packs |
| Recall Reason | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. |
| Drug Classification | Class II |
| Drug Code Info | 20250212 |
| Recall Initiation Date | 20250124 |
| Report Date | 20250212 |
| Classification Date | 20250203 |
| Address | 625 Kolter Dr Ste 4 Indiana, PA 15701-3571 United States |
| Recalling Firm | RemedyRepack Inc. |
| Initial Notification | Letter |
| Similar To |