Recall | Veterinary Medicines | 11/10/2018

The marketing authorization holder has informed its supplied customers by letter dated 09/10/2018 that an atypical trend in the level of non-specified impurities has been detected in terbinafine - one of the three active ingredients in Osurnia. Currently, the batch is within specifications. However, the impurities will be exceeded by the end of shelf life (02/2021), therefore a precautionary and voluntary recall is already being issued.

Name of the medicinal product OSURNIA Ohrengel für Hunde
Marketing authorisation number(s) EU/2/14/170/0003
Marketing authorisation holder Elanco Europe Ltd
Batch number(s) 20882
Classification of the recall3
BASG reference number INS-640.001-2649

Further inquiry note