The marketing authorization holder informed its supplied customers in a letter dated June 18, 2013, that due to an individual complaint from the German market regarding a plastic ampoule leaking at the neck of the bottle, batch 12FHL21 will be replaced as a precautionary measure.
|Name of the medicinal product||Peditrace - Infusionszusatz|
|Marketing authorisation number(s)||1-20857|
|Marketing authorisation holder||Fresenius Kabi Austria GmbH|
|Classification of the recall||2|
|BASG reference number||INS-640.001-0797|