Preflucel (Drei Chargen)
In a letter dated October 27, 2011, the marketing authorization holder informed its customers 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 product information.
Since the cause of these observations has not yet been clarified, the marketing authorization holder has decided to extend the recall to all batches on the market.
|Name of the medicinal product||PREFLUCEL Injektionssuspension in einer Fertigspritze|
|Marketing authorisation number(s)||2-00373|
|Marketing authorisation holder||Baxter AG |
Baxter Healthcare GmbH
|Batch number(s)||VNV5L010A, VNV5L011A, VNV5L012B|
|Classification of the recall||2|
|BASG reference number||INS-640.001-0262|