Recall | Medicines | 01/04/2011

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) 1-28834
Marketing authorisation holder EBEWE Pharma Ges.m.b.H. Nfg. KG
Batch number(s) 95457806
Classification of the recall1
BASG reference number INS-640.001-0078

Further inquiry note