Product: Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm 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: 20241230
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated