A number of batches of adrenaline pens used in the emergency treatment of acute allergic reactions have been recalled.
The Health Products Regulatory Authority (HPRA) announced that PharmaSwiss is recalling all batches of Emerade 150mcg pre-filled pens, Emerade 300mcg pre-filled pens and Emerade 500mcg pre-filled pens.
The recall is taking place as some Emerade pens may fail to produce an injection when used, due to failure of the pen to activate and the potential for a blocked needle.
The HPRA has called on anyone who possesses an Emerade pen for their own use or for someone in their care to ensure that their pens are brought back to their pharmacy and immediately replaced with an alternative product.
No other brand of adrenaline pens is impacted by this recall.
The affected products are all batches of:
The HPRA advised users of the recalled products that, if they have not yet been contacted by their pharmacist, that they should check for any Emerade pens in their possession and in other locations.
"If you are in the possession of any Emerade pen, please return it to your pharmacy where you will receive a replacement alternative product. In line with existing medical guidelines, it is advised that patients continue to carry two pens at all times," said a statement.
Emerade is administered through a pre-filled pen, or autoinjector.
The reason for the recall is that a number of reports of failure to activate have been received on other markets.
The cause of these activation failures and the defect rate remain unknown.
This is also a separate issue to a potential needle blockage issue for Emerade pens which was previously communicated by the HPRA in July 2018 and July 2019.
It is possible, however, for both defects to be present in a pen with the potential for failure of administration of the medication.