Dianeal

Recall | Medicines | 05/01/2011

Two batches of the product Dianeal have been identified that may contain endotoxins. Therefore, the marketing authorization holder has decided to recall the above mentioned batches from a dialysis center supplied in Austria.

Name of the medicinal product 1. Dianeal PD4 Glucose 1,36% w/v/13,6 mg/ml –
Peritonealdialyselösung

2. Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml –
Peritonealdialyselösung
Marketing authorisation number(s) 1. 1-21583
2. 1-21584
Marketing authorisation holder Baxter Healthcare GmbH
Batch number(s) 1. 10A20G30
2. 10I17G30
Classification of the recall1
BASG reference number 640.297/2010
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