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  1. Recalls (Biologics)

Product Information Advisory - Albumin Human 25% Solution (AlbuRx 25)


DATE INFORMATION ADVISORY INITIATED: November 9, 2017

PRODUCT / LOT NUMBER:

AlbuRx 25
50 mL and 100 mL expiring on or before May 30, 2020

MANUFACTURER:

CSL Behring LLC
Kankakee, IL

REASON:

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 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.

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.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.