Drug product
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
D-0189-2025
Product summary
- Event
- Event 96074
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 73,680 bottles
- Official record key
drug-enforcement:D-0189-2025
Official wording
Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Code information: Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations