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ISSUE: 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.
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.
BACKGROUND: AlbuRx 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood.
RECOMMENDATION: CSL Behring recommends inspecting vial labels for readability ...