Replacement | Medicines | 04/07/2013

The distribution partner "sanofi-aventis GmbH" informed its supplied customers in a letter dated 04.07.2013 that the retained samples of the above batch showed deviations. After a storage time of 26 months, aggregates above the permissible limit of 5% were detected. As the batch is still within the period of 36 months, a recall was carried out.

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, Niederlande

Vertrieb und Durchführung Austausch:
sanofi-aventis GmbH, Österreich
Batch number(s) C1270H17
Classification of the recall2
BASG reference number INS-640.001-0814

Further inquiry note