Drug product
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
D-0573-2025
Product summary
- Event
- Event 97360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
drug-enforcement:D-0573-2025
Official wording
Reason: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Code information: Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
Distribution pattern: Nationwide Within the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations