Albumex (human albumin solutions), 9 March 2012

Medicine recall

Published

9 March 2012

Level:	Hospital
Class:	I
Reference:	RC-2012-RN-00257-3
Date agreed:	09 March 2012
Product:	The products being recalled under the Albumex® range are: Albumex 4 500mL, Australian Register of Therapeutic Goods (ARTG) AUST R 59155 Albumex 4 50mL, AUST R 59154 Albumex 20 100mL, AUST R 46283 Albumex 20 10mL, AUST R 31820 All batches manufactured prior to 25 January 2012 are affected. Affected batch numbers (see below).
ARTG number:	see above
Batch number:	See below
Sponsor:	CSL Limited
Customer information:	CSL is asking customers (i.e., hospitals/ distributors) to quarantine any batches of Albumex that are within their control until further notice. New batches manufactured after 25 January 2012, will be tested for the presence of ethylene glycol prior to releasing them to the market. Quarantined stocks will be replaced as new unaffected stock becomes available.
Contact:	Customers requiring additional information can contact CSL Biotherapies Medical Information on 1800 642 865.
Reason:	Some batches of Albumex manufactured prior to 25 January 2012 may be contaminated with very low levels of ethylene glycol as a consequence of an equipment failure.

Batch numbers affected

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.