Other safety alerts
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| Australia: TGA approves release of cleared batches of Albumex 4 and Albumex 20 from quarantine |
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Australia:
1. TGA approves release of cleared batches of ALBUMEX
10 March 2012: On 8 March 2012, the TGA announced that CSL Biotherapies had advised that some batches of its human albumin product (ALBUMEX) had been contaminated with ethylene glycol. As a public health measure, TGA quarantined all batches of the product pending further analysis. To expedite re-supply of ALBUMEX for essential health care requirements, the TGA is allowing CSL Biotherapies to release batches of the product from quarantine where TGA is satisfied that testing of those batches has been undertaken to an appropriate standard, and that this testing demonstrates that the batch does not contain harmful levels of ethylene glycol. The quarantine release process requires CSL Biotherapies to arrange testing of each batch according to protocols agreed by TGA, and provide the results to the TGA for assessment. The tests being undertaken are sufficiently sensitive to detect ethylene glycol at or above 0.5 parts per million (ppm), which is well below the internationally accepted safety limit for this compound. TGA will audit the manufacturing process at CSL Biotherapies and will independently test some batches of ALBUMEX as a quality assurance measure. This testing by TGA will not delay release of ALBUMEX batches for essential health care requirements. Release of specified batches has now commenced.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-human-albumin-120310.htm
2. Batches of CSL human albumin (Albumex 4, Albumex 20) released from quarantine
11 March 2012: The batches listed below have been released from quarantine by the TGA following testing that demonstrates that they do not contain harmful levels of ethylene glycol: 3450700296, 3470100407, 3450700298, 3450700301, 3450700299, 3450700315, 3450700323, 3450700316, 3470550454, 3470550453 and 3450700317.
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 March 2012 and 10 March 2012. Department of Health will keep vigilant about the latest development.
Ends/ Monday, March 12, 2012
Issued at HKT 12:30
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