The marketing authorization holder informed its supplied customers in a letter dated October 24, 2012, that there is a possible pyrogen contamination in the two batches listed above.

Dermapharm GmbH 1354427 2/26/13 Einstimmig Bescheid Bescheid für zulassungspflichtige Änderungen Gelofusin - Infusionslösung 1-18490 B. Braun Melsungen AG 1354214 2/26/13 Einstimmig Bescheid Zulassungsv

Referenced at:

• BASG approval procedure