Emerade 150 micrograms auto-injectors recalled in UK
Posted: 6 March 2020 | Victoria Rees (European Pharmaceutical Review) | No comments yet
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.
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.
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Related organisations
UK Department of Health & Social Care (DHSC), UK Medicines and Healthcare products Regulatory Agency (MHRA)
