Class II
Ongoing
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
This recall is currently active, issued August 13, 2025. It was issued by Cardinal Health Inc..
- Company
- Cardinal Health Inc.
- Recall Initiated
- July 30, 2025
- Posted
- August 13, 2025
- Recall Number
- D-0573-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3 units
- Firm Location
- Dublin, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Distribution
Nationwide Within the U.S.
Lot / Code Info
Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
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