Drug product
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
D-0009-2025
Product summary
- Event
- Event 95508
- Status
- Completed
- Classification
- Class II
- Quantity
- 7,107 bottles
- Official record key
drug-enforcement:D-0009-2025
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Code information: Lot #: 220128, Exp. Date 12/2024
Distribution pattern: Product was distributed nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations