Drug product

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

D-0516-2026

April 29, 2026

Class II

Product summary

Firm: Ajanta Pharma Ltd.
Event: Event 98785
Status: Ongoing
Classification: Class II
Quantity: 117,168 packs
Official record key: drug-enforcement:D-0516-2026

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#: PA10734, Exp. Jun 2026.

Distribution pattern: Nationwide within U.S

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

N-nitroso-Duloxetine impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations