DULOXETINE HYDROCHLORIDE Recall D-0387-2025
Description: Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
DULOXETINE HYDROCHLORIDE Recall D-0387-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0387-2025 |
| Event ID | 96707 |
| Brand | DULOXETINE |
| Generic Name | DULOXETINE HYDROCHLORIDE |
| Manufacturer | DULOXETINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | DULOXETINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | US Nationwide. |
| Quantity | 16,473 bottles |
| Recall Reason | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. |
| Drug Classification | Class II |
| Drug Code Info | 20250430 |
| Product NDC | 51991-746 51991-747 51991-748 |
| Recall Initiation Date | 20250414 |
| Report Date | 20250430 |
| Classification Date | 20250422 |
| Address | 15 Massirio Dr Ste 201N/A 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) | 32327581-bdab-41ac-9adc-bf208e1c4e42 |
| Structured Product Labeling (SPL Set ID) | caef6f50-1571-4ec7-8f8c-42b924d323ee |
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