The Paul-Ehrlich-Institut has withdrawn the official batch release for some human albumin batches of the Marketing Authorisation Holder (MAH) Biotest Pharma GmbH (Germany). This affects 250 ml vials of "Albiomin 5%" as well as 50 ml and 100 ml vials of "Albiomin 20%" manufactured between 2013 and 2016 (see list below). The MAH has voluntarily initiated a recall of affected batches that are already on the market.
Owing to a technical defect, the batches of human albumin were contaminated with a cooling agent. Small quantities of ethylene glycol, the main component of the cooling agent, were detected in some doses of the human albumin batches. Furthermore, the batches are likely to have been contaminated with traces of other chemicals contained in the cooling agent. To our present knowledge, there is considered to be little likelihood of severe adverse events due to the contamination. The contaminated batches have been classified as unsafe on account of the quality defect, and their use has therefore been prohibited.
Pharmacies are no longer allowed to dispense the affected albumin batches. Batch release withdrawal concerns all batches containing human albumin manufactured in the affected vessel since 2013. As an initial measure, the MAH placed all the affected batches under quarantine on 13th April 2017.
The recall relates to the following batches released in Germany:
B231016 B231026 B231086 B231176 B231264 B231294 B231295
B231325 B231326 B231345 B231364 B231386
B234055 B234286 B234304 B234404 B234535 B234665 B234986
B235024 B235394
B236045 B236085 B236165 B236186 B236275 B236286 B236314
B236335 B236366 B236384 B236425 B236454 B236465 B236486
B236505 B236635 B236684 B236704 B236724
The recall also affects batches marketed outside Germany:
Updated: 27.04.2017
