Thymoglobulin
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 recall | 2 |
| BASG reference number | INS-640.001-0506 |
Further inquiry note
Page last modified:
12/07/2022