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FDA Medwatch Alert: Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label
Posted 5 Dec 2017 by Drugs.com
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 ... Read more
Related support groups: Alburx
Posted 30 Apr 2015 by Drugs.com
THURSDAY, April 30, 2015 – Children undergoing heart surgery do better when they get fresh whole blood from single donors instead of "component blood" from multiple donors, new research suggests. But fresh whole blood isn't typically available for pediatric heart surgery patients, said study leader Dr. David Jobes, of the Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania in Philadelphia. "We hope that our research helps to re-examine current blood storage practice and make whole blood more readily available for pediatric patients," Jobes added. The findings are published in the May issue of Annals of Thoracic Surgery. Patients given blood or blood components can experience allergic reactions or serious complications such as lung injury and infectious disease, the researchers noted. "The risk for disease transmission in pediatric ... Read more
Related support groups: Blood Transfusion, Albumin Human, Cardiothoracic Surgery, Dextran-HM, Plasmatein, Kedbumin, Macrodex, Dextran, Low Molecular Weight, Albuminar-5, Gentran 40, Protenate, Alburx, Plasbumin-20, Plasma Protein Fraction, Hespan, Buminate, Plasbumin-5, Voluven, Human Albumin Grifols, Albumarc