Albumex (human albumin solutions), 9 March 2012

Related information

Medicine recall

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.