Drug product

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

D-0617-2026

June 22, 2026

Class II

Product summary

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

Code information: Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.

Distribution pattern: U.S. Nationwide

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