Patient level recall of all batches of Emerade adrenaline auto-injector pens

News Category: 3rd party

Date: 30/09/2019

Users advised to exchange Emerade pens at their pharmacy

The HPRA today advises that PharmaSwiss (Ceska republika s.r.o.) is recalling all lots (batches) of Emerade 150mcg pre-filled pens, Emerade 300mcg pre-filled pens and Emerade 500mcg pre-filled pens. These products are used for the emergency treatment of acute allergic (anaphylactic) reactions. 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. Anyone who possesses an Emerade pen for their own use or for someone in their care is urged to ensure that their pens are brought back to their pharmacy and immediately replaced with an alternative product. The HPRA states that no other brand of adrenaline pens is impacted by this recall.

The affected products are all batches of:

  • Emerade 150mcg pre-filled pens
  • Emerade 300mcg pre-filled pens
  • Emerade 500mcg pre-filled pens

Advice to Patients and Carers:

  • If you have not as yet been contacted by your pharmacist, please check for any Emerade pens in your 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.

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 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.

Emerade is indicated as an emergency supportive therapy to treat severe anaphylaxis in children and adults. In line with current medical guidelines, it is advised that patients carry two pens at all times. In addition, patients should seek immediate medical attention following administration of any autoinjector. 

Should patients have any concerns in relation to this matter, they should consult their doctor or pharmacist.


Specific information for Pharmacists:

All pharmacists registered in Ireland were sent advance information about this recall on 27 September, 2019.  

View the recall letter sent by the Marketing Authorisation Holder to pharmacies. This states the requested actions for carrying out this recall to patient level.

Media queries:
Weber Shandwick PR               01 679 8600
Siobhan Molloy/Sean Lawless  086 817 5066

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