Drug product
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
D-0161-2025
Product summary
- Event
- Event 95853
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 163,883 bottles
- Official record key
drug-enforcement:D-0161-2025
Official wording
Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Code information: Lot # 222205C, exp. date 11/2025
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations