MedicineWatch US
Class II Recall

Cardinal Health Inc.

Product
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Classification
Class II
Status
Ongoing
Lot
Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
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.