Drug product
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
D-0277-2025
Product summary
- Event
- Event 96427
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1223 bottles
- Official record key
drug-enforcement:D-0277-2025
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Code information: Lot #: DTB23111A, Exp 8/31/2025
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations