Recall D-0573-2025

US Class II Ongoing · initiated 2025-07-30

Recalling firm

Cardinal Health Inc., OH

Product

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

Reason for recall

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

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