Product: 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
Reason for recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated: 20250414
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated