Ireland’s Health Products Regulatory Authority (HPRA) announced today it is recalling all Emerade epinephrine auto-injectors in 150mcg, 300mcg and 500mcg doses.
The reason for the recall is that some devices may fail to deliver epinephrine properly when activated due to mechanical failure or the potential for the needle to be blocked. The exact cause of the mechanical failures and the rate of defects are not known.
All holders of Emerade brand auto-injectors are urged to return their devices to their pharmacy for a replacement alternative.
A spokesman for the HPRA said: “This is 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 this potentially life-saving medication.”
This recall does not affect the US where Emerade brand auto-injectors are not sold.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) warned of a critical fault in Emerade brand auto-injectors in July 2019. The agency could not issue a recall at the time due to a shortage of alternative devices.
UK Warns of Critical Fault in Emerade Brand Auto-Injector, Can’t Issue Recall Due to Shortage