Drug product

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

D-0555-2026

May 14, 2026

Class II

Product summary

Firm: Asclemed USA Inc.
Event: Event 99019
Status: Ongoing
Classification: Class II
Quantity: 50 bottles
Official record key: drug-enforcement:D-0555-2026

Official wording

Reason: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

Code information: Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026

Distribution pattern: US Nationwide.

Derived failure modes

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

Nitrosamine Drug Substance Related Impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations