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Originator: National Patient Safety Alert - MHRA

Issue date: 09-May-2023 12:34:17

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Regional Offices
  • Ofsted recipients
  • Social Care Providers (registered with CAS)
  • Special Health Authorities
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Community Pharmacy
  • Primary Care Networks
  • GP Practices 1

Action category: Action

Title: Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure

Broadcast content: 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.

The attached National Patient Safety Alert contains further information and actions for providers.

Also attached is a letter containing advice for patients who have been prescribed an Emerade auto-injector.




Additional information: NHS England Regions: please cascade this alert to Community Pharmacy. Please also cascade to Dental and Optometry contractors in case such auto-injectors are held on site.

Alert reference: NatPSA/2023/004/MHRA

Action underway deadline: 11-May-2023

Action complete deadline: 12-May-2023

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency