The distribution company Novartis Pharma GmbH has informed its supplied customers in a letter dated March 19, 2012, that due to water ingress in the manufacturer's warehouse, a batch of the injection syringes included in the Rabipur vaccine kit has become moist. Due to this moisture on the primary packaging of the enclosed application syringes, the sterility of these syringes may theoretically be impaired. Therefore, the above Rabipur batches are being recalled in Austria as a precautionary measure.
It is pointed out that the vaccine powder as well as the solvent to be used do not represent a quality defect in principle or have not come into contact with water in any case. To date, no adverse drug reactions have been reported that could indicate an increased risk following administration of the aforementioned vaccine batches.
|Name of the medicinal product||Rabipur Pulver und Lösungsmittel zur Herstellung einer Injektionslösung|
|Marketing authorisation number(s)||2-00293|
|Marketing authorisation holder||Novartis Vaccines and Diagnostics GmbH |
Vertrieb & Durchführung Austausch:
Novartis Pharma GmbH
|Batch number(s)||490011E, 493011C|
|Classification of the recall||2|
|BASG reference number||INS-640.001-0364|