D-0573-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 13, 2025
- Initiation Date
- July 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
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 Pattern
Nationwide Within the U.S.
Code Information
Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025