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.
Recall initiated: 20250730
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated