Other safety alerts
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| Australia: Release of batches of Albumex 4 and Albumex 20 from quarantine only applies to batches manufactured before 25 January 2012 |
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TGA has conducted an audit of CSL's albumin manufacturing process with particular focus on the root cause of the ethylene glycol contamination. The audit concluded that the cause of the contamination was due to a leak of ethylene glycol from a crack in a heating/cooling jacket surrounding a tank used to store albumin solution. The TGA has verified that the crack has been repaired and that the cause of the problem has been rectified. Ethylene glycol has not been detected in batches of albumin produced after the repair was undertaken. On this basis, and with a view to minimising delays in accessing albumin solutions, TGA has agreed that the release procedure involving TGA's batch-by-batch review of CSL's ethylene glycol test results need not apply to batches of albumin solution manufactured after 25 January 2012. This means the release process and the batches listed will only apply to batches produced before 25 January 2012. Therefore customers need to be aware that they may receive batches of albumin solution that are not listed.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-human-albumin-120311.htm
In Hong Kong, Albumex 5 Infusion 12.5g/250ml (HK-58570) and Albumex 20 Infusion 10g/50ml (HK-58571) are registered by HK Red Cross Blood Transfusion Service, and are prescription-only medicines. Department of Health was informed by the company on 8 March 2012 regarding the news. Subsequently a total recall of the above products was initiated in Hong Kong and press release was issued on the same day. The news has been released by the TGA and Singapore HSA and was posted on the website of Drug Office on 9 - 10 March and 12 - 14 March 2012.
Ends/ Thursday, March 22, 2012
Issued at HKT 12:30
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