FDA recall D-0573-2025

Cardinal Health Inc. · Class II · drug

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.

Distribution

Nationwide Within the U.S.

Key facts

Status
Ongoing
Initiation date
2025-07-30
Report date
2025-08-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0573-2025