CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Classification
Class II
Status
Completed
Lot
Lot #: 220128, Exp. Date 12/2024
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.
Breckenridge Pharmaceutical, Inc — Class II Recall | MedicineWatch US