Alerts and recalls

Alerts and recalls

9 March 2012 - CSL Biostate safety
CSL Biotherapies notified the TGA on 7 March 2012 that some batches of human albumin solutions manufactured by CSL in Australia prior to 25 January 2012 have been contaminated with ethylene glycol as a consequence of an equipment failure.

As a result the Therapeutic Goods Administration took steps to quarantine all batches of albumin in hospitals around Australia until further tests were conducted to ensure the safety of the product.

As human albumin is also used in the manufacture of plasma derived factor VIII, Biostate, people with haemophilia A who use this product may be concerned. However, the TGA has issued an advice today that the small amounts of ethylene glycol in Biostate are unlikely to pose a health risk. If anyone who uses Biostate remains concerned they should contact their doctor for further information.

Imported recombinant clotting factor products are not affected by this incident. CSL has also advised HFA that neither Prothrombinex – VF (PTX) nor MonoFIX ( pdFIX) contain albumin.

http://www.tga.gov.au/safety/alerts-medicine-biostate-powder-120309.htm

Last Updated: 9th Mar 12