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Albumex (human albumin solutions), 9 March 2012

Medicine recall
Published
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

Batch numbers affected
345050027334505002753450500304345070022434507002273450700228
345070022934507002303450700231345070023234507002353450700236
345070023734507002383450700239345070024034507002423450700244
345070024734507002483450700249345070025034507002513450700252
345070025334507002563450700257345070026034507002623450700264
345070026534507002663450700267345070026834507002693450700271
345070027434507002763450700278345070027934507002823450700283
345070028534507002863450700287345070028834507002903450700293
345070029634507002983450700299345070030034507003013450700307
345070030834507003093460650020346065002134606500233470100299
347010030134701003343470100337347010034834701003683470100384
347010040734705002953470500296347050029734705003163470500319
347050032234705003253470500332347050033934705003413470500345
347050034634705003563470500359347050029034705504203470550416
347055041834705003663470500371347050037334705003743470500380
347050038534705003923470500398347050040134705004043470500414
347050042134705004463470550291347055029234705503023470550313
347055031434705503153470550317347055032034705503233470550326
347055032734705503313470550344347055034934705503423470550335
347050044134705503553470550357347055036134705503633470550365
347055037234705503753470550379347055038134705503823470550387
347055038934705503903470550394347055040034705504023470550403
347055040534705504113470550412347055033834705503403470550343
34705503533470550354    

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.

Product types