Fasturtec 1,5 mg Pulver und Lösungsmittel zur Herstellung eines Infusionslösungskonzentrats
Recall
|
Medicines
|
28/08/2020
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 |
| CIP code | 2433921 |
| Marketing authorisation holder | sanofi-aventis groupe |
| Distributor | Sanofi-Aventis GmbH |
| Batch number(s) | A9306 |
| Expiry date | 02/28/2022 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3287 |
Further inquiry note
Page last modified:
28/08/2020