Drug product
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.
D-0511-2025
Product summary
- Event
- Event 97179
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12,242 30-count bottles
- Official record key
drug-enforcement:D-0511-2025
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Code information: Lot # 230199, Exp. Date 01/31/2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations