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

Recall Number: D-0562-2024

Firm: Breckenridge Pharmaceutical, Inc

Classification: Class II

Status: Terminated

Report Date: 20240626

Initiation Date: 20240517

Termination Date: 20260407

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

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