Recall D-0277-2025
Recalling firm
Rising Pharma Holding, Inc., NJ
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.