RECALL OF EMERADE 300 AND 500 MICROGRAM
ADRENALINE AUTOINJECTOR DEVICES
9th May 2023
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.
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).
- Patients should contact their GP (by telephone) to get a replacements prescription for their (or their child’s) Emerade 300/500 microgram auto-injector pen(s),
- When collecting their replacement pens, patients (and their caregivers) must be trained in how to use the new device.
- The recalled Emerade devices should be returned to their local pharmacy.
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:
- EpiPen® devices: http://www.EpiPen.co.uk/patients/EpiPenr-user-guide
- EpiPen® 0.3mg: https://www.medicines.org.uk/emc/product/4289/rmms
- Jext® devices: https://jext.co.uk/
- Jext® 300 Training Video: https://www.medicines.org.uk/emc/product/5748/rmms
For further information, please see the MHRA notice, available here.