← FDA ENFORCEMENT
D-0573-2025Class II

Cardinal Health Inc.

Recalling firm
Cardinal Health Inc.
Product type
Drug
Status
Ongoing
Report date
2025-08-13
Distribution
Nationwide Within the U.S.
Firm state
OH
Product quantity
3 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Product description

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

Code / lot info

Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.