Cardinal Health Inc. recalls RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142
Recalled August 13, 2025 · FDA recall D-0573-2025 · Cardinal Health
Hazard
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. · FDA Class II
Units
3 units
Sold at
Nationwide Within the U.S.
Description
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Product
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Manufacturer(s)
Cardinal Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →