Recall | Medicines | 21/04/2016

The marketing authorization holder informed its supplied customers in a letter dated 19.04.2016 that an error in the filling process was detected at the manufacturer. The error results in a few vials possibly containing a too high concentration. The too high concentration results from the partial evaporation of the solvent ethanol, but the total amount of active ingredient per vial is not affected. In Austria, this affects the two batches listed above, which are now being recalled.

Name of the medicinal product 1. Taxotere20mg/1ml Konzentrat zur Herstellung einer Infusionslösung
2. Taxotere 80mg/4ml Konzentrat zur Herstellung einer Infusionslösung
Marketing authorisation number(s) 1. EU/1/95/002/003
2. EU/1/95/002/004
Marketing authorisation holder Aventis Pharma S.A.

Durchführung Rückruf:
sanofi-aventis Österreich GmbH
Batch number(s) 1. 5F218A
2. 5F219A
Classification of the recall2
BASG reference number INS - 640.001 - 1689

Further inquiry note