Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Reason
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Classification
Class II
Status
Ongoing
Lot
a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Rising Pharma Holding, Inc. — Class II Recall | MedicineWatch US