May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Details
Product
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Recalling company
Cardinal Health Inc.
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide Within the U.S.
Initiated
Jul 30, 2025
FDA report date
Aug 13, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.