Drug product
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.
D-0552-2025
Product summary
- Event
- Event 97276
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,829 60-count bottles
- Official record key
drug-enforcement:D-0552-2025
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Code information: Lot: 230836C, Exp.: 02/28/2026
Distribution pattern: U.S Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations