Drug product

Duloxetine Delayed-Release Capsules, USP, 60 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 82009-032-10

D-0580-2025

July 25, 2025

Class II

Product summary

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Code information: Lot 240539C, Exp 1/31/2027

Distribution pattern: NJ, AZ, IN

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