Drug product
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
D-0165-2025
Product summary
- Event
- Event 95900
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a) 1,564 cards, b) 799 bottles
- Official record key
drug-enforcement:D-0165-2025
Official wording
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Code information: a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations