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 |
Baxter Healthcare GmbH
|Classification of the recall||2|
|BASG reference number||INS-640.001-0262|