Replacement | Medicines | 24/10/2011

The marketing authorization holder informed its supplied customers in a letter dated October 24, 2011, that a precautionary recall is being carried out due to an increased number of suspected cases of adverse drug reactions that occurred within a short period of time. The previous reports of adverse drug reactions mainly concerned hypersensitivity reactions, which are listed in the current technical information. Investigations of all process steps at the manufacturer have been started and are still ongoing.


Name of the medicinal product PREFLUCEL Injektionssuspension in einer Fertigspritze
Marketing authorisation number(s) 2-00373
Marketing authorisation holder Baxter AG

Durchführung Austausch:
Baxter Healthcare GmbH
Batch number(s) VNV5L010A
Classification of the recall2
BASG reference number INS-640.001-0262

Further inquiry note