Kexxtone 32.4g continuous-release intraruminal device for cattle, EU/2/12/145/001-003
The Direct animal Healthcare Professional Communication (DaHPC) provides additional information in relation to this issue, and can be downloaded in the Documents section at the bottom of this webpage.
The reason for the recall is due to a quality defect which has resulted in cases where cattle regurgitated the device while it still contained monensin tablets. This resulted in increased accidental exposure, including deaths, in non-target species (dogs) and potential lack of efficacy in cattle.
Product information
- Active substance
- Monensin (as monensin sodium)
- Authorisation holder
- Elanco Animal Health
- Authorisation number
- EU/2/12/145/001-003
- Serial or batch number and expiry date
- All in-date batches
- Human or veterinary medicine
- Veterinary
- Target audience
- Veterinarians, pharmacists, wholesalers
- Recall level
- Veterinary / pharmacy level
Actions to be taken
Information for Veterinarians / Pharmacists
Veterinarians / pharmacists are requested to:
- Check your current inventory and immediately quarantine any units of this product which you have in your veterinary surgery or pharmacy.
- If you have supplied units of this product to any other surgery, pharmacy or any other healthcare facility, please contact them and request that they return any unused units to you.
- Contact the wholesaler from which you purchased the stock to arrange for the return of all quarantined units. Please return stock by 13th June 2024.
We apologise for any inconvenience this action may cause. Should you have any queries, please contact Elanco at telephone number 01 256 353131.
Information for Users and the Public
If you have this medication in your possession and have any queries, please contact your veterinarian or pharmacist.
Suspected adverse reactions should be reported to Elanco and the Health Products Regulatory Authority (medsafety@hpra.ie).