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

Recall Number: D-0483-2024

Firm: Breckenridge Pharmaceutical, Inc

Classification: Class II

Status: Ongoing

Report Date: 20240515

Initiation Date: 20240429

Termination Date:

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

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