Albumex (human albumin solutions), 18 April 2012
|Date agreed:||17 April 2012|
|Product:||Albumex 4 500mL|
|Expiry||17 November 2015|
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:
|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.|
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.