Recalls / Class II
Class IID-0573-2025
Product
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
- Affected lot / code info
- Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
Why it was recalled
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recalling firm
- Firm
- Cardinal Health Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 3 units
- Distribution pattern
- Nationwide Within the U.S.
Timeline
- Recall initiated
- 2025-07-30
- FDA classified
- 2025-08-07
- Posted by FDA
- 2025-08-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0573-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.