Fasturtec 1,5 mg Pulver und Lösungsmittel zur Herstellung eines Infusionslösungskonzentrats
The marketing authorisation holder informed its customers by August 27, 2020 that stability studies have shown a deviation in rasburicase enzyme activity affecting the US market. However, based on the investigations, it is assumed that this deviation was caused by a non-conforming filling volume of the vials. A low filling volume may lead to a potential lack of efficacy. Therefore all batches that might be affected will be recalled as a precautionary measure. In Austria batch number A9306 is affected by the recall.
|Name of the medicinal product||Fasturtec 1,5mg/ml Pulver und Lösungsmittel zur Herstellung eines Infusionslösungskonzentrats|
|Marketing authorisation number(s)||EU/1/00/170/002|
|Marketing authorisation holder||sanofi-aventis groupe|
|Classification of the recall||2|
|Depth of recall||Pharmacies|
|BASG reference number||INS-640.001-3287|