CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Classification
Class II
Status
Ongoing
Lot
Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
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.
Ascend Laboratories, LLC — Class II Recall | MedicineWatch US