Class II · Moderate risk Terminated
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed…
Reason cGMP Deviations: Temperature excursion
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
What was recalled
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
- Recalling firm
- Cardinal Health Inc.
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0573-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Recombinant recalls
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Class II · Moderate risk Terminated
Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box containing a 5000-unit vial of RECOTHROM with a 5-mL…
Reason cGMP deviations: Temperature abuse
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