Albumin Human 25 Percent Solution - Product Information Advisory

PUBLISHED: Dec 1, 2017
Relevant to: Critical Access Hospitals, Hospitals, Pharmacies

During routine inspection of retained AlbuRx 25% samples, CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear off portion of the vial label. This is limited to 50 and 100 mL vial sizes.

AlbuRx 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood.

CSL Behring is taking no action with products on the market but is addressing the print settings to ensure readability throughout the shelf life of the product. If the lot number and expiration dating is not able to be verified, customers are asked to contact CSL Customer Support.

CSL Behring recommends inspecting vial labels for readability and fading. If fading is evident refer to the immediate carton for lot number and expiration dating. Additionally, the lot number is imprinted on the vial aluminum seal.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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