Albumex (human albumin solutions), 18 April 2012

Medicine recall

Published

18 April 2012

Level:	Hospital
Class:	I
Reference:	RC-2012-RN-00257-3
Date agreed:	17 April 2012
Product:	Albumex 4 500mL
ARTG number:	59155
Batch number:	3450700309
Expiry	17 November 2015
Sponsor:	CSL Limited
Customer information:	CSL Biotherapies has now completed ethylene glycol testing of all affected batches of Albumex 4 and Albumex 20 which were the subject of the original quarantine process announced on 9 March 2012. The testing was undertaken to determine those batches that can be released from quarantine and any batches requiring recall from supply. CSL Biotherapies has investigated 96 batches of the quarantined human albumin using protocols acceptable to the TGA. The results identified: 78 batches contain no detectable ethylene glycol and now may be released from quarantine 18 batches contain low levels of ethylene glycol, and of these only one batch of Albumex 4 (3450700309), which has been quarantined in Australian hospitals and at the Australian Red Cross Blood Service (ARCBS) is being recalled. 12 batches are quarantined in warehouses at CSL Biotherapies. The remaining 5 batches have been exported and CSL is recalling these batches from the overseas market.
Contact:	Customers requiring additional information can contact CSL Biotherapies Medical Information on 1800 642 865.
Reason:	CSL Biotherapies is recalling the above batch of Albumex 4, due to the presence of ethylene glycol at a concentration of ≥ 0.5 mg/L.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.