Albumin quarantine
March 9, 2012
YESTERDAY the Therapeutic
Goods Administration ordered a
quarantine of CSL Human Albumin
solutions held by hospitals, the
Australian Red Cross Blood Service
and CSL, pending the results of an
assessment into the safety of these
products.
The quarantine follows reports
from CSL Biotherapies that some
batches of human albumin solution
manufactured prior to 25 January
2012 have been contaminated with
ethylene glycol as a consequence of
an equipment failure.
“CSL has advised the TGA that the
levels of contamination which have
been detected are very low and
that, based on projections of the
highest possible amounts
administered and available
toxicological data, adverse clinical
effects appear unlikely to occur,” a
TGA statement said.
According to CSL a review of
adverse event reporting had shown
no evidence of issues associated
with the use of the product, with
any toxicity due to ethylene glycol
occurring acutely, with delayed
effects beyond 72 hrs not expected.
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