Multi event Drug Recall Enforcement Report Class II voluntary initiated by Breckenridge Pharmaceutical, Inc, originally initiated on 12-06-2024 for the product Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. The product was recalled due to cgmp deviations: presence of n-nitroso-duloxetine impurity above fda recommended interim limit.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0162-2025 | 12-06-2024 | 01-01-2025 | Class II | 76,968 bottles | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Ongoing |
| D-0161-2025 | 12-06-2024 | 01-01-2025 | Class II | 163,883 bottles | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Ongoing |
Recalled Products
