Recall D-0165-2025
Description: Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Recall D-0165-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0165-2025 |
| Event ID | 95900 |
| Distribution | Nationwide in the US |
| Quantity | a) 1,564 cards, b) 799 bottles |
| Recall Reason | CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. |
| Drug Classification | Class II |
| Drug Code Info | 20250101 |
| Recall Initiation Date | 20241202 |
| Report Date | 20250101 |
| Classification Date | 20241226 |
| Address | 625 Kolter Dr Ste 4 Indiana, PA 15701-3571 United States |
| Recalling Firm | RemedyRepack Inc. |
| Initial Notification | Letter |
| Similar To |