National Patient Safety Alert: Class 1 medicines recall notification - Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure

Summary

Pharmaswiss Česka republika s.r.o. and distributor Bausch & Lomb UK Limited is recalling all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens) from patients. This is due to an issue identified during an ISO 11608 Design Assessment study where some auto-injectors failed to deliver the product or activated prematurely.

Specifically, the 1-metre free-fall (vertical orientation) pre-conditioning resulted in damage to internal components of the auto-injector, leading either to failure to deliver the product or premature activation. This damage was not visibly apparent following the pre-conditioning but was evident only on subsequent functional testing. It is unclear what impact this has on auto-injectors in clinical use, however as a precautionary measure and owing to the inability to identify this issue before the auto-injectors are used, the auto-injectors are being recalled.

Healthcare professionals should inform patients, or carers of patients, who carry Emerade 300 or 500 microgram auto-injector pens to obtain a prescription for and be supplied with an alternative brand. They should then be informed to return their Emerade 300 or 500 microgram pens to their local pharmacy.

Actions

Actions required to complete by 12 May 2023:

The action to recall should be coordinated by the Chief Pharmacist/Superintendent Pharmacist/Responsible Pharmacist, Dispensing GPs and GP practices in the first instance. The below actions should be initiated by General Practitioners (GPs) and Pharmacy Teams immediately.

• Stop supplying the impacted products immediately. Quarantine all remaining stock and return it to your supplier/MAH using your supplier’s approved process.
• Identify patients who have been supplied with Emerade 500 micrograms and Emerade 300 micrograms auto-injectors and ensure that they are reviewed by their prescriber 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 Emerade 500 micrograms and Emerade 300 micrograms auto-injector with an adrenaline pen in an alternative brand. Epipen 300 or Jext 300 are appropriate alternatives to Emerade 500 micrograms. Dosing recommendations are available in the Summary of Product Characteristics (SmPC) and should be followed (see links below).
• Inform patients to return Emerade 500 micrograms and Emerade 300 micrograms auto-injectors to any pharmacy after they have obtained a total of two equivalent strength adrenaline pens in an alternative brand.
• General Practitioners (GPs) and Pharmacy Teams should send the linked letter “Advice for patients who have been prescribed Emerade auto-injectors”, to all patients and carers who have been prescribed Emerade auto-injectors.