Product: Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Reason for recall: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated: 20241206
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated