Other safety alerts
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| The United States: Product Information Advisory - Albumin Human 25% Solution (AlbuRx 25) |
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The Unitd States (US) Food and Drug Administration (FDA) announces that 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 of AlbuRx 25 50 mL and 100 mL expiring on or before May 30, 2020 during routine inspection of retained AlbuRx 25% samples. The products are manufactured by CSL Behring LLC, Kankakee, IL. The incident 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 in US 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.
Please refer to the following website in FDA for details:http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/../ucm587162.htm
In Hong Kong, Alburx 25 Solution For Infusion 250g/L 50ml (HK-63901) and Alburx 25 Solution For Infusion 250g/L 100ml (HK-63900) are pharmaceutical products registered by CSL Behring Asia Pacific Limited (CSL Behring). As confirmed with CSL Behring, the incident in US has no impact on the products marketed in Hong Kong.
Ends/Friday, December 1, 2017
Issued at HKT 15:00
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