Class IIReported 2025-03-19

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

Reason for Recall

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

Recall Number

D-0271-2025

Classification

Class II

Status

Ongoing