FDARecalled Aug 13, 2025 · #D-0573-2025
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Hazard
Class II — temporary health risk
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CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. Classification: Class II Distribution: Nationwide Within the U.S.
Product details
- Product
- RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
- Type
- Drugs
- Manufacturer
- Cardinal Health Inc.
- Model numbers
- TRB23802AC
- UPCs
- —