DGAP-News
Biotest AG: Voluntary recall of human albumin
DGAP-News: Biotest AG / Key word(s): Profit Warning / |
PRESS RELEASE
Biotest: Voluntary recall of human albumin
- Already quarantined batches of human albumin are recalled
- Consequences of the one-time effect on Sales and EBIT are currently being evaluated
- As a precaution, guidance is being reduced
Dreieich, 26 April 2017 Today, Biotest has informed its customers about the recall of several batches of human albumin. The batches in question had already been quarantined by Biotest as a precautionary measure on 13 April 2017. Since that day, no affected product had been used. By recalling the affected products, Biotest ensures that all products are being returned.
An equipment failure in the production of an albumin intermediate gave reason for this action. The equipment failure has already been fixed.
The recall is performed in close co-operation with the regulatory authorities. Further information is available on our website: http://www.biotest.com/de/en/products.cfm
After repairing of the equipment failure, the original production range has already been reached again. This one-time effect will only impact the fiscal year 2017. Consequences on Sales and EBIT are currently being evaluated. As a precaution, Biotest reduces its Sales guidance from low single-digit growth rate to the level of the previous year and its EBIT guidance of EUR46 to EUR48 million by EUR25 to EUR30 million.
About Human Albumin
Albumin is used in particular in intensive care medicine and acute care. Patients with extensive blood or fluid loss, due to burns among other things, have too little of the important proteins in
their blood. This protein loss is compensated by administering Albumin. Albumin is also used for volume replacement in cases of blood poisoning. Unlike synthetically manufactured drugs, Albumin
produced from human plasma offers particularly good tolerability. It is also the most important protein carrier in the blood for binding and removing (harmful) substances from the vascular system.