The distributor informed its customers on June 10, 2022 that a deviation of the test results from the specification for this batch has been detected. The suspected microbial contamination is currently being investigated.
This batch is being recalled as a precaution.
The medicinal product is authorised in Germany.
|Name of the medicinal product||BioBag 50|
|Marketing authorisation number(s)||74483.00.00 (Germany)|
|Marketing authorisation holder||Biomonde GmbH|
|Distributor||sorbion Mayrhofer GmbH|
|Classification of the recall||2|
|BASG reference number||INS-640.001-3906|