Drug product

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

D-0514-2026

April 29, 2026

Class II

Product summary

Firm: Ajanta Pharma Ltd.
Event: Event 98785
Status: Ongoing
Classification: Class II
Quantity: 312,894 packs
Official record key: drug-enforcement:D-0514-2026

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#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.

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