FDA-Drug2025-08-13Class II
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Cardinal Health Inc.
Hazard
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Sold states
Nationwide Within the U.S.
Affected count
3 units
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0573-2025Don't want to check this manually?
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