Product: Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ  NDC 57237-017-60
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