Drug product

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10

D-0621-2025

August 08, 2025

Class II

Product summary

Reason: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Code information: Lot 240927C, Exp 04/30/2027

Distribution pattern: AZ, IN, NJ

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