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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

Batch numbers affected
3450500273	3450500275	3450500304	3450700224	3450700227	3450700228
3450700229	3450700230	3450700231	3450700232	3450700235	3450700236
3450700237	3450700238	3450700239	3450700240	3450700242	3450700244
3450700247	3450700248	3450700249	3450700250	3450700251	3450700252
3450700253	3450700256	3450700257	3450700260	3450700262	3450700264
3450700265	3450700266	3450700267	3450700268	3450700269	3450700271
3450700274	3450700276	3450700278	3450700279	3450700282	3450700283
3450700285	3450700286	3450700287	3450700288	3450700290	3450700293
3450700296	3450700298	3450700299	3450700300	3450700301	3450700307
3450700308	3450700309	3460650020	3460650021	3460650023	3470100299
3470100301	3470100334	3470100337	3470100348	3470100368	3470100384
3470100407	3470500295	3470500296	3470500297	3470500316	3470500319
3470500322	3470500325	3470500332	3470500339	3470500341	3470500345
3470500346	3470500356	3470500359	3470500290	3470550420	3470550416
3470550418	3470500366	3470500371	3470500373	3470500374	3470500380
3470500385	3470500392	3470500398	3470500401	3470500404	3470500414
3470500421	3470500446	3470550291	3470550292	3470550302	3470550313
3470550314	3470550315	3470550317	3470550320	3470550323	3470550326
3470550327	3470550331	3470550344	3470550349	3470550342	3470550335
3470500441	3470550355	3470550357	3470550361	3470550363	3470550365
3470550372	3470550375	3470550379	3470550381	3470550382	3470550387
3470550389	3470550390	3470550394	3470550400	3470550402	3470550403
3470550405	3470550411	3470550412	3470550338	3470550340	3470550343
3470550353	3470550354

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.