FDAHealthJuly 30, 2025
Cardinal Health Inc. — RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
⚠️ CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 30, 2025
Nationwide Within the U.S.
What's affected?
- Product
- RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
- Brand
- Cardinal Health Inc.
- Lot code
- TRB23802AC
Additional details
Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3 units.
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