Product: Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle,  Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated: 20240517
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated