Replacement | Medicines | 19/06/2013

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
Batch number(s) 12FHL21
Classification of the recall2
BASG reference number INS-640.001-0797

Further inquiry note