Drug product
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
D-0562-2024
Product summary
- Event
- Event 94611
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165,678, 90-count bottles
- Official record key
drug-enforcement:D-0562-2024
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Code information: Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations