DULOXETINE HYDROCHLORIDE Recall D-0161-2025
Description: 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.
DULOXETINE HYDROCHLORIDE Recall D-0161-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0161-2025 |
| Event ID | 95853 |
| Brand | DULOXETINE |
| Generic Name | DULOXETINE HYDROCHLORIDE |
| Manufacturer | DULOXETINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | DULOXETINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the US |
| Quantity | 163,883 bottles |
| Recall Reason | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. |
| Drug Classification | Class II |
| Drug Code Info | 20250101 |
| Product NDC | 51991-746 51991-747 51991-748 |
| Recall Initiation Date | 20241206 |
| Report Date | 20250101 |
| Classification Date | 20241223 |
| Address | 15 Massirio Dr Ste 201 Berlin, CT 06037-2352 United States |
| Recalling Firm | Breckenridge Pharmaceutical, Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9044SC542W |
| Drug Application Number | ANDA203088 |
| Structured Product Labeling (SPL ID) | 7dbd50a3-bb9b-4ae5-a3e3-fef39f6be304 |
| Structured Product Labeling (SPL Set ID) | caef6f50-1571-4ec7-8f8c-42b924d323ee |
| Similar To |