Product: Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Reason for recall: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall initiated: 20241230
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated