Recall | Medicines | 28/04/2017

The marketing authorization holder has informed its supplied customers in a letter dated April 27, 2017, that the affected batches are being recalled due to a possible minor contamination with ethylene glycol. According to current knowledge, the occurrence of side effects due to the contamination for patients is unlikely.

Name of the medicinal product 1) Albiomin 50 g/l Infusionslösung
2) Albiomin 200 g/l Infusionslösung
Marketing authorisation number(s) 1) Zulassungsnummer: 2-00359
2) Zulassungsnummer: 2-00360
Marketing authorisation holder Biotest Pharma GmbH
Batch number(s) Albiomin 50 g/l, 250 ml:
B231015, B231066, B231075, B231076, B231086, B231154, B231155, B231164, B231166, B231186, B231196, B231205,
B231214, B231234, B231245, B231296, B231315, B231325, B231335, B231354, B231364, B231374, B231375, B231465,
B231475, B231485, B231515, B231525
Albiomin 200 g/l, 50 ml:
B234065, B234375, B234455, B234534, B234575, B234675, B234975, B235094, B235124, B235135, B235256, B235464,
B235474, B235525, B235535, B235546
Albiomin 200 g/l, 100 ml:
B236046, B236065, B236066, B236085, B236095, B236196, B236225, B236235, B236245, B236256, B236286, B236304,
B236314, B236326, B236336, B236345, B236376, B236434, B236444, B236455, B236475, B236476, B236484, B236505,
B236515, B236526, B236536, B236546, B236576, B236585, B236605, B236694, B236714, B236106
Classification of the recall1
BASG reference number INS-640.001-2082

Further inquiry note