Osurnia
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 recall | 3 |
| BASG reference number | INS-640.001-2649 |
Further inquiry note
Page last modified:
12/07/2022