Recombinate antihemophilic factor vials exposed to temperatures outside labeled storage
Recombinate [Antihemophilic Factor (Recombinant)] 5 mL vials are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 3 units affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall over a storage temperature excursion, with no confirmed potency or stability failure stated in the source.
Plain-English summary
Recombinate, Antihemophilic Factor (Recombinant), 5 mL vials, prescription only, from Takeda Pharmaceuticals USA of Cambridge, Massachusetts, NDC 00944-2843-01, is being recalled. The action covers 3 units.
The stated reason is CGMP deviations: the product was exposed to temperatures outside the product's labeled storage requirements. The FDA classified the action as Class II. The source does not report any confirmed loss of potency or stability.
Affected lots are TRB23802AC expiring 03/18/2026 and TRA22804AA expiring 10/18/2025. Distribution was nationwide within the US.
Patients and facilities holding affected lots should follow the instructions issued by Takeda.
The recalled product
- Product
- RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Injectable biologic
- Hazard
- temperature-excursion
- cold-chain
- cgmp-deviation
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: TRB23802AC
- Expires: 03/18/2026
- TRA22804AA
- Expires: 10/18/2025
Distribution
Distributed nationwide across the United States.
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