Product: Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Recall initiated: 20250715
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated