Safety Notices

The purpose of these notices relating to the safety and/or quality of medicinal products is to update users and health care professionals of important changes to medicines, and to explain the reasons for those changes. The notices are classified under a number of categories and may relate to human and veterinary medicines, or medical devices.   

The issues covered by these notices will range from quality defect information and medicinal product safety information through to updated information on the appropriate usage of medicines or devices.

Notices are categorised in accordance with their importance at time of publication.

The four notice categories are outlined as follows:

 
  • Advisory        Routine safety information
  • Warning         Urgent safety information
  • Recall             Urgent safety information relating to a product recall
  • Publications  General safety information provided by the HPRA for publication via 3rd parties e.g. EMA

Date Title Type
30/05/2024 Recall notice for all in-date batches of Kexxtone 32.4g continuous-release intraruminal device for cattle, EU/2/12/145/001-003 Recall
27/05/2024 Safety warning relating to Kexxtone 32.4 g continuous-release intraruminal device for cattle (monensin) from Elanco GmbH For Immediate Action
04/04/2024 Prescribers and users of closantel-containing products are reminded to ensure accuracy of dosing in order to avoid residue violations in treated animals Advisory
19/03/2024 Recall notice for Purevax® RCP FeLV lyophilisate and solvent for suspension for injection, EU/2/04/048/001-004 and Purevax® RCP lyophilisate and solvent for suspension for injection, EU/2/04/052/001-004 Recall
14/03/2024 Recall of one batch of Semintra® 4 mg/ml Oral Solution for Cats, EU/2/12/146/001 Recall
07/12/2023 Recall notice for one batch of Finadyne® 50 mg/ml Solution for Injection (VPA10996/228/001) Recall
16/10/2023 Labelling requirements for veterinary medicines supplied in Ireland Advisory
04/10/2023 Recall notice for RenuTend suspension for injection for horses, EU/2/22/282/001 Recall
27/09/2023 Recall notice for Clavudale 400 mg/100 mg tablets for dogs, VPA22622/005/003 Recall
30/06/2023 Update - Recall notice for Versifel FeLV, Suspension for Injection for Cats, VPA10387/088/001 Recall