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FDA Alert: Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory

FDA Alert: Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory

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December 1, 2017

Audience: Risk Manager, Critical Care Medicine, Emergency Medicine

[Posted 12/01/2017]

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 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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/30/2017 – Product Information Advisory – FDA]

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