Product: Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recall initiated: 20241119
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated