Pharmaswiss Česka republika s.r.o. and distributor Bausch & Lomb UK Limited is recalling all unexpired batches of Emerade 300 and Emerade 500 micrograms adrenaline auto-injectors (also referred to as pens).
This is due to a concern that the device may not work or activate prematurely, if the device has been knocked (for example, by being dropped). It is unclear how this may affect using the pen. In addition, pens that may have internal damage are not easily identified. The recall is a precautionary measure. The MHRA, in conjunction with the Department of Health & Social Care (DHSC), has confirmed that there are sufficient supplies of alternative auto-injectors to allow for a recall at patient level.
If you have been prescribed Emerade 500 micrograms or Emerade 300 micrograms auto-injectors, also known as Emerade pens, you should contact your GP or pharmacist immediately to get replacements. You should get two alternative auto-injectors of a different brand, such as EpiPen or Jext.
Once you have obtained the replacement pens, even if your Emerade pens are still in date, it is crucial to return them to a pharmacy. Additionally, you must receive proper training on how to use the new devices as each brand of adrenaline auto-injector has different instructions. This training is vital to ensure you are fully acquainted with the correct usage of the new device.
You can read the full Patient Information Letter from MHRA here.
Healthcare professionals should inform patients prescribed Emerade 300/500 (or their caregivers) to obtain a prescription for an alternative brand (EpiPen 300 or Jext 300 micrograms).
A single EpiPen (300 micrograms) or Jext (300 micrograms) pen is a suitable replacement for a single Emerade 500 micrograms pen. This is based on data from two studies (including one by Bausch & Lomb) which found that a 300 microgram dose given by EpiPen or Jext achieves the same adrenaline level in the blood as Emerade 500.
Patients must continue to always carry two adrenaline pens at all times.
Different brands of adrenaline pens work differently. Patients and carers should be told of these important differences. The following links provide training materials for the different devices:
For further information, please see the MHRA notice, available at GOV.UK
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