Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10

Recall Number: D-0387-2025

Firm: Breckenridge Pharmaceutical, Inc

Classification: Class II

Status: Ongoing

Report Date: 20250430

Initiation Date: 20250414

Termination Date:

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10