FDA Issues Product Advisory for CSL Behring’s AlbuRx
- By BSTQ Staff
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. The issue is limited to 50 mL and 100 mL vial sizes. While CSL Behring is taking no action with product on the market, it is addressing the print settings to ensure readability throughout the shelf life of the product. CSL Behring recommends inspecting vial labels for readability and fading. If fading is evident, the immediate carton can be referred to for lot number and expiration dating. In addition, the lot number is imprinted on the vial aluminum seal. If the lot number and expiration dating are not able to be verified, customers are asked to contact CSL customer support at (800) 683-1288.
References
- Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory—Fading Print On Label. U.S. Food and Drug Administration press release, Dec. 11, 2017. Accessed at www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm587337.htm.
