Thymoglobulin
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 recall | 2 |
BASG reference number | INS-640.001-0814 |
Further inquiry note
Page last modified:
12/07/2022