Product: Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Reason for recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall initiated: 20241202
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated