Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

Recall Number: D-0009-2025

Firm: Breckenridge Pharmaceutical, Inc

Classification: Class II

Status: Completed

Report Date: 20241023

Initiation Date: 20241010

Termination Date:

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

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.