Replacement | Medicines | 13/08/2012

The distribution partner sanofi-aventis GmbH Austria informed its supplied customers by letter dated August 13, 2012, that aggregates above the specification limit of 5% occurred after reconstitution of reserve samples of a batch sold in the USA. As a precautionary measure, a recall has been initiated for batches produced during the same period and under the same conditions, as they show comparable trends in the stability profiles.

Name of the medicinal product Thymoglobuline 5 mg/ml - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Marketing authorisation number(s) 2-00167
Marketing authorisation holder Genzyme Europe BV

Durchführung Austausch:
sanofi-aventis GmbH Österreich
Batch number(s) C0066H11, C0070H07, C0074H14
Classification of the recall2
BASG reference number INS-640.001-0506

Further inquiry note