Safety Notices

From time to time notices relating to the safety and/or quality of medicinal products are published by the Health Products Regulatory Authority

These notices are classified under several priority related 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
06/12/2018 Recall by Norbrook of one batch of Alamycin LA 200 mg/ml Solution for Injection and one batch of Vitesel Suspension for Injection to Veterinary Surgeon / Pharmacy level in Ireland Recall
03/12/2018 Duotech Oral Suspension for Sheep, Parafend Plus Oral Suspension - Change to the meat withdrawal period Advisory
01/08/2018 Recall of One Batch of Bovaclox Milking Cow Intramammary Suspension to User Level in Ireland Recall
27/07/2018 HPRA commences procedure to consider precautionary restrictions on the use of veterinary medicinal products containing the excipient diethanolamine Advisory
04/07/2018 Removal of the indication for treatment of infections caused by E. coli in chickens and/or turkeys for veterinary medicinal products (VMPs) containing enrofloxacin that are administered via the drinking water. Advisory
26/04/2018 Advisory notice relating to eye injuries in humans and dogs when using Osurnia ear gel for dogs Advisory
05/04/2018 Update on pharmacovigilance activities concerning veterinary medicinal products in the European Union during 2017 Advisory
13/03/2018 Recall of One Batch of Oxytobel 10 IU/ml Solution for Injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats to Veterinary Surgeon Level in Ireland Recall
19/01/2018 Flukicides containing oxyclozanide. Changes to the withdrawal periods Advisory
19/01/2018 Gentamicin containing products presented as solutions for injection to be administered to cattle and pigs – changes to the withdrawal periods Advisory