The government has issued an urgent recall of all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors from patients, due to a risk of device failure if the pen has been dropped.

Patients should be told to obtain a prescription for and be supplied with an alternative brand, and should then return their Emerade 500 or 300 microgram pens to their local pharmacy.

Following a test of a one-meter free-fall, some of the pens failed to deliver the product or activated prematurely.

‘It is unclear what impact this has on auto-injectors in clinical use, however as a precautionary measure and owing to the inability to identify this issue before the auto-injectors are used, the auto-injectors are being recalled,’ the Medicines and Healthcare products Regulatory Agency (MHRA) said today.

Future production of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors is on hold, which means that patients will need to be switched to an appropriate alternative.

The MHRA said that in conjunction with the Department of Health and Social Care (DHSC) it had established that there were sufficient supplies of alternative auto-injectors to allow for a recall at patient level.

Alternative brands EpiPen and Jext are available in a maximum strength of 300 micrograms, and the MHRA said that there was evidence to suggest that a single EpiPen (300 micrograms) or Jext (300 micrograms) pen would be a suitable replacement for a single Emerade 500 micrograms pen.

The MHRA told healthcare professionals to inform patients to obtain a prescription for an alternative brand, and when prescribing and dispensing should give the patient training on how to use their new device, since each brand of adrenaline auto-injector works differently.

Patients should continue to carry two devices at all times in case they need to administer a second dose of adrenaline before the arrival of the emergency services, the MHRA reminded them.

Community pharmacies should stop supplying Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors immediately, quarantine all remaining stock and return it to their supplier, it added.

They should identify patients who have been supplied with Emerade 500 and 300 microgram pens and ensure that they are reviewed by their prescriber. They should also immediately inform patients and carers to request a new prescription to replace each Emerade 500 micrograms and Emerade 300 micrograms pens with an alternative brand, and issue them with an advisory letter.

After patients have received two equivalent strength adrenaline pens in an alternative brand, they should return their Emerade 500 micrograms and Emerade 300 micrograms auto-injectors to any pharmacy.