Emerade 150 micrograms auto-injectors recalled in UK

The UK MHRA has announced that Emerade 150 micrograms solution for injection is being recalled due to an error in one component of the auto-injector.

Adrenaline auto-injector

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a Class 2 medicines recall for Emerade 150 micrograms (mcg) solution for injection in a pre-filled syringe, PL 33616/0013. 

The company which produces the syringe, Pharmaswiss Česka republika (an affiliate of Bausch & Lomb UK Limited), is recalling all unexpired batches of the auto-injectors (also referred to as pens) from patients due to an error in one component of the auto-injector believed to cause some pens to fail to activate and deliver adrenaline.

Results from manufacturer testing of Emerade auto-injectors recalled from patients in Europe indicate that approximately 13 percent of pens need higher than normal force to activate, implying a higher risk of activation failure than was previously understood. This applies to all strengths of Emerade, says the MHRA. 

For Emerade 150mcg auto-injectors, the MHRA, in conjunction with the Department of Health & Social Care (DHSC) has established that there are sufficient supplies of alternative auto-injectors to allow for a recall to patient level.

GPs have been asked to send an approved letter to the appropriate patients and carers who have been prescribed Emerade 150mcg auto-injectors.

Healthcare professionals who prescribe, supply or administer adrenaline auto-injectors, or who advise patients and their carers, should ensure that they:

  • identify patients who have been supplied with Emerade 150mcg auto-injectors and ensure they are reviewed to determine whether their adrenaline auto-injector prescription is still appropriate and in line with existing guidance
  • immediately inform patients and carers to request a new prescription to replace each auto-injector with one new adrenaline pen in an alternative brand. Healthcare professionals should be aware that the licensed dosing recommendations for each brand of pen are not identical. 
  • inform patients to return the syringes to the pharmacy, only when they have two alternative adrenaline auto-injectors in their possession.

More information about the recall can be found here