Class IIReported 2025-08-13

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.

Recall Number

D-0573-2025

Classification

Class II

Status

Ongoing