Class 2 Medicines recall: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (EL(19)A/39)

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerede Adrenaline Autoinjectors after identifying an error than can cause some pens to fail to activate.

MDR Number

MDR 57-08/19

Company name

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited)

Product description

Product PL Number
Emerade 150 micrograms solution for injection in pre-filled syringe PL 33616/0013
Emerade 300 micrograms solution for injection in pre-filled syringe PL 33616/0014
Emerade 500 micrograms solution for injection in pre-filled syringe PL 33616/0015

Brief description of the problem

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of the above product due to an error in one component of the autoinjector believed to cause some pens to fail to activate and deliver adrenaline. More information is provided in attachment below.

Emerade stock held by patients is not being recalled, and patients and caregivers in possession of Emerade pens need to be informed of updated safety information about the risk of failure to activate.

Advice for healthcare professionals

Stop supplying the above product immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Healthcare professionals are urged to share the additional information below with all patients and carers who have been prescribed an Emerade pen.

Contact details for further information

For stock enquiries please contact Bausch & Lomb Customer Services, Tel: 0208 781 2991 Email: Pharma_CS@bausch.com

For medical information enquiries please contact the Pharmacovigilance and Medical Information Officer, Tel: 0208 781 5523, Email: Pharmacovigilance.UK@bausch.com

Further information

  • Reports have emerged that Emerade adrenaline pens (autoinjectors) have failed to activate. A previous drug alert was issued on 03 October 2019.

  • The company’s investigations have now shown that an error in one component of the autoinjector is believed to cause some pens to fail to activate and deliver adrenaline. There is an increased likelihood of the activation fault occurring when pens are exposed to high temperature. Patients should be advised not to expose pens to temperatures above 25°C as this may increase the likelihood of the fault occurring.

  • On the basis of all the information available, most Emerade pens will activate as normal and patients are advised to continue to follow existing advice to carry two in-date pens with them at all times.

  • Prescribers should prescribe adrenaline pens (autoinjectors) of another brand, until this error has been corrected and ensure that training is provided for the alternative brands.

  • In the UK, there are insufficient supplies of alternative brands to replace all the Emerade pens held by patients.

  • No further supplies of Emerade will be available until the issue has been fully resolved.

  • The advice is that those patients who have been supplied with Emerade pens should continue to use the pens as instructed. When the Emerade pen has expired, patients should be prescribed a different brand (EpiPen or Jext). Patients and carers will need to be made aware of the difference in administration of the pen they are supplied with, that will require training in use of the new pen. Further information can be found in the Patient Information Leaflets of the different pens.

  • The advice to continue using Emerade pens until the expiry date has been considered in order to avoid a serious shortage of adrenaline pens for the wider patient community. The MHRA and Department of Health and Social Care consider that the risk of not having a pen is much higher than having a pen that may not activate.

  • Prescribers and patients can be reassured that where a patient has been supplied with Emerade 500 mcg adrenaline pens, EpiPen and Jext in strengths of 300 mcg (0.3 mg) will be appropriate alternatives. The licensed dosing recommendations for each brand of pen is available in the Summary of Product Characteristics (SmPC) and should be followed.

  • If an Emerade adrenaline pen fails to activate immediately, an additional attempt should be made using an increased force when pressing the pen against the intended injection site.

  • If the first pen does not activate, despite use of increased force, the patient should immediately use their second pen.

  • Patients who have been supplied with Emerade pens should avoid exposing pens to temperatures above 25°C, in line with the recommended storage conditions. If travel to a hot climate is anticipated, the patient is advised to also carry an alternative brand of pen.

Activation issue

  • Emerade 150/300/500 micrograms solutions for injection are approved for treating severe acute allergic reactions (anaphylaxis).

  • Complaints that Emerade pens (autoinjector) have failed to activate have been received.

  • Bausch and Lomb believe a likely contributory cause of the activation failure to be an error in the manufacturing of one of the components of the pen.

  • This error may under some circumstances, such as exposure to high temperature, cause misalignment of two components, and could potentially lead to failure to activate, even if higher activation force is used.

  • The MHRA, along with the Department of Health and Social Care are working to stabilise the supply of adrenaline pens.

Information for patients

The MHRA has provided additional information (see pages 4 and 5 of Class 2 Medicines Recall Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-0819)) for patients and carers who have Emerade pens. Information is provided on the activation failures and advice on how to handle an emergency event should a pen fail to activate and how to tell whether this has occurred by inspection of the pen.

Healthcare professionals are urged to share this information with all patients and carers who have been prescribed an Emerade pen.
It is important to report all suspected adverse reactions or product quality defects via the Yellow Card reporting tool, yellowcard.mhra.gov.uk - patient should be advised to retain the pen if possible.

Additional advice to patients and carers with Emerade pens

Don’t expose Emerade pens to heat or keep them somewhere hot

This fault may be more likely to happen if the pen is exposed to temperatures higher than 25°C. Therefore, make sure you protect it from heat and do not leave your pen in a hot place (for example, in front of a heater, radiator, or fire). This instruction is not new, and you can find out more about how to store your pen safely in the leaflet that comes with it. Contact your doctor if you are planning to travel to somewhere hot since you may need a different pen for this trip.

Most pens will continue to work; carry two pens and use if you need to

In the UK, there are not enough adrenaline pens in alternative brands to replace all the Emerade pens held by patients. Most Emerade pens will continue to work. Therefore, the risk of not having a pen is much higher than the risk of having a pen that may not activate. If you have been given an Emerade pen, continue to use it as instructed. If your first Emerade pen does not activate despite firm pressure, immediately use your second pen. Always carry two adrenaline pens with you and use them if you need to.

When your Emerade pen expires, learn how to use your new type of adrenaline

When your Emerade pen has expired (the end of the month listed on the pen and case), you will be prescribed a different brand of adrenaline (EpiPen or Jext). There are some differences between brands. You and the people around you will need to be aware of these difference in how to use the pen(s) you have been supplied with. The manufacturers of the different devices have training information, including videos of how to use them correctly, on their websites. Trainer pens (mock pens that do not contain adrenaline) are also available to be ordered on the websites.

See Class 2 Medicines Recall Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-0819) for more information

What to do if you suspect anaphylaxis

  • Use the autoinjector at first signs of anaphylaxis. As a precaution you should press the pen very firmly against the thigh.

  • If this does not result in activation, you should immediately use your second pen. See Class 2 Medicines Recall Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-0819) to illustrate what a non-activated pen looks like

  • Call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna -fill-axis’)

  • Lie flat if possible with your legs up to keep your blood flowing. However, if you are having difficulty breathing, you may need to sit up to make breathing easier

  • Use second pen if still unwell after 5-15 minutes

  • If a further dose of adrenaline is needed before the emergency services arrive, additional attempts should be made to administer a pen that has failed to activate. This is because reports received suggest that a pen may activate after further attempts.

There is also a fact sheet with advice on the use of adrenaline auto-injectors which patients or carers are encouraged to read.

The risk of device mishandling or device failure exists with all adrenaline auto-injectors and is something that patients and carers should be aware of.

The chance of a successful outcome is increased if there is prompt administration of adrenaline at the first signs of anaphylaxis.

Even with an apparently successful response to adrenaline auto-injector administration, patients may relapse some hours later which underlines the importance that the emergency services should always be called.

Additional information

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.

Download the document

Class 2 Medicines Recall Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-0819)

Published 28 November 2019