Patient level recall of all in-date batches of Emerade auto adrenaline injection products in Ireland

Notice type: Recall

Date: 30/09/2019


Product name or type:
Emerade 150 micrograms solution for injection in pre-filled pen, Emerade 300 micrograms solution for injection in pre-filled pen and Emerade 500 micrograms solution for injection in pre-filled pen

QDR-H-19-640, QDR-H-19-641 and QDR-H-19-641

Authorisation Number:
PA1696/009/001, PA1696/009/002 and PA1696/009/003

Active Substance:

Adrenaline (as adrenaline tartrate)

Product Classification:

Prescription-only medicine

Serial Or Batch Number And Expiry Date:

All in-date batches 

Authorisation Holder:
PharmaSwiss Česká republika s.r.o., an affiliate of Bausch & Lomb U.K. Limited
Jankovcova 1569/2c, 170 00 Prague 7, Czech Republic 

Prescription Required:

Recall Classification:
Wholesale, pharmacy and patient level 

Target Audience:
Patients, Carers, Pharmacists, Wholesalers 

Problem Or Issue:

The HPRA advises that PharmSwiss Ceska republika s.r.o., an affiliate of Bausch & Lomb U.K. Limited, is recalling all in-date batches of Emerade adrenaline auto-injector pens to patient level with immediate effect.

The reason for the recall is that a number of reports of pens failing to activate (i.e. deliver a dose) have recently been received for Emerade from other markets. The cause of these activation failures and the defect rate remain unknown. This is a separate issue to the potential needle blockage issue for Emerade pens which was previously communicated by the HPRA in July 2018 and July 2019. It is possible for both defects to be present in a pen and there is the potential for the pen to fail to deliver the dose.   

Actions To Be Taken:

Advice to Patients and Carers

Pharmacists have been asked to contact their patients or carers, to ensure the return of any units of Emerade.

If you have not as yet been contacted, please check for any Emerade pens in your possession and in other locations. All batch numbers are being recalled.

If you are in the possession of any Emerade pen, please return it to your pharmacy where you will receive a replacement alternative product.

Should you have any queries, please contact your pharmacist or doctor.

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.

Specific information for Wholesalers

Wholesalers which received in-date stock of Emerade have also been sent a recall letter.

Further Information:

No other Adrenaline Auto-injector brand is affected by this recall action.

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