Product: Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall initiated: 20250305
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated