Drug product
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
D-0515-2026
Product summary
- Event
- Event 98785
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 77,376 packs.
- Official record key
drug-enforcement:D-0515-2026
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Code information: Lot#: PA07434, Exp. May 2026.
Distribution pattern: Nationwide within U.S
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-Duloxetine impurity
-
Manufacturing or process control
CGMP Deviations