Product: Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, 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