FDA Recall Ongoing Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- July 16, 2025
- Distribution
- Nationwide
