D-0552-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 13, 2025
- Initiation Date
- July 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,829 60-count bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Distribution Pattern
U.S Nationwide
Code Information
Lot: 230836C, Exp.: 02/28/2026