Medicine Recall - Emerade

All in-date batches of Emerade solution for injection pre-filled pens were recalled in Ireland on September 30 2019, following a number of reports on other markets of failure to activate. 

Any failure to activate could result in a failure of administration of this potentially life-saving medication. 

While the recall action extended to patient level, as agreed with the Health Products Regulatory Authority (HPRA), Bausch Health has recently received information which indicates that not all pens at patient level were actually returned during the 2019 recall. 

Recently Bausch Health was notified of a pen failure which occurred in Ireland:

• The pen failed to activate when the patient went to use it. 
• The patient was carrying only one pen and subsequently required emergency hospital treatment. 
• That pen should have been captured in the 2019 recall action, but for whatever reason, it remained at patient level after the recall.

The 2019 recall action has, to date, captured 56% of the Emerade pens that were potentially on the market at the time of the recall - 44% of in-date pens may remain at patient/carer level at this time. The last batch on the market is labelled with an October 2020 expiry date.

If you have any adrenaline auto-injector products within your clinic, or in your medical bag, please check if they are Emerade pens. If they are Emerade pens, please return the pens to the dispensing pharmacy to replace with an alternate product. 

Also, we kindly ask you to please check with any patients (or their carers) who visit your clinic and who are known to have been prescribed an adrenaline auto-injector, whether they have any in-date Emerade pens in their possession, at any location - you may need to ask this of these patients (or their carers) on every visit, unless and until the answer is 'no'. If a patient (or their carer) has in-date Emerade pens, please advise them that those pens are the subject of a recall action and to immediately return the pens to their pharmacy.

Alternative adrenaline auto-injector products are available. 

Lastly, please remind patients (or their carers) that it is advised to carry two pens at all times, in line with existing medical guidelines,

Reporting of suspected adverse reactions:

Reports of suspected adverse reactions may be reported to the HPRA. Any suspected adverse reactions should be reported to the HPRA, via the online reporting option on the website www.hpra.ie and by e-mail: medsafety@hpra.ie.

By reporting side effects, you can help provide more information on the safety of this medicine.