Class IIReported 2025-01-01

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Reason for Recall

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

Recall Number

D-0162-2025

Classification

Class II

Status

Ongoing