Thymoglobulin
Replacement
|
Medicines
|
06/03/2014
The distributor has informed its supplied customers in a letter dated March 5, 2014, that ten batches were identified during investigations that showed an increased risk of out-of-specification (OOS) values for the parameter "polymers, aggregates and fragments" before expiry of shelf life. Only one batch (batch C1274, not marketed in Austria) showed out-of-specification values, nevertheless all batches involved in the investigations are being recalled as a precautionary measure. In Austria, this concerns two of the ten batches tested.
| 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 Rückruf: sanofi-aventis GmbH, Österreich |
| Batch number(s) | C1282H28, C1284H10 |
| Classification of the recall | 3 |
| BASG reference number | INS - 640.001 - 1043 |
Further inquiry note
Page last modified:
12/07/2022