The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert regarding the possible malfunction of Emerade 300 µg EpiPens.
All unexpired batches of Emerade 300 µg auto-injectors are being recalled due to an error in one component of the auto-injector which may cause some pens to fail to activate and deliver adrenaline.
The MHRA is advising health care professionals in primary, secondary or specialist health care services who prescribe, supply or administer adrenaline auto-injectors, or who advise patients and their carers, to identify patients who have been supplied with Emerade 300 µg auto-injectors and ensure they are reviewed to determine whether the auto-injector prescription is still appropriate and in line with existing guidance.
A new prescription should be issued to replace each Emerade 300 µg auto-injector with a new adrenaline pen in an alternative brand.
Prescribers should issue no more than two adrenaline auto-injectors of any brand or strength.
The exceptions are when EpiPens are stored at more than one location, for example, at school, or the rare scenario where patients might need more than two adrenaline pens prescribed, for example, a prior severe reaction resistant to treatment with adrenaline.
The MHRA has developed a patient information letter which GPs should send to their patients who are using an Emerade 300 µg auto-injector.
