December 6, 2017

FDA issues Safety Alert on human albumin 25% solution (AlbuRx 25) by CSL Behring

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on December 1 issued a Safety Alert for human albumin 25% solution (AlbuRx 25) by CSL Behring LLC (Kankakee, Illinois).

During routine inspection, the company noted the potential for fading print on 50 mL and 100 mL vials, with more effect on the expiration dating on the patient tear off portion of the vial label.

CSL Behring is not taking any action with products on the market but is addressing the print setting to ensure readability throughout the product’s shelf life. If the lot number and expiration date can’t be verified, customers should contact CSL Behring customer support.

 

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