Drug product
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
D-0188-2025
Product summary
- Event
- Event 96074
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 42,527 bottles
- Official record key
drug-enforcement:D-0188-2025
Official wording
Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Code information: a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, 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