RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Reported: August 13, 2025 Initiated: July 30, 2025 #D-0573-2025
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.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 3 units
- Distribution
- Nationwide Within the U.S.
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01. Recalled by Cardinal Health Inc.. Units affected: 3 units.
Why was this product recalled? ▼
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 13, 2025. Severity: Moderate. Recall number: D-0573-2025.
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