In a letter dated March 30, 2011, the marketing authorization holder informed its supplied customers of a precautionary recall, as isolated precipitations of the active ingredient within the shelf life of the prepared infusion solution specified in the instructions for use have been reported from other countries.
|Name of the medicinal product
|Ebedoce 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
|Marketing authorisation number(s)
|Marketing authorisation holder
|EBEWE Pharma Ges.m.b.H. Nfg. KG
|Classification of the recall
|BASG reference number