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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 18-May-2020 10:59:31

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • Social Care Providers (registered with CAS)
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • DHSC Supply Disruption - Medicines
  • Primary Care Networks

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, PATIENT LEVEL RECALL, CESKA REPUBLIKA S.R.O (AN AFFILIATE OF BAUSCH AND LOMB UK LIMITED), EMERADE 500 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Broadcast content:
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 microgram 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. More information is provided in the attached alert.

Healthcare professionals (GP Practices, Pharmacies) should, contact patients and carers with Emerade 500mcg pens, to inform them of the recall information contained within this alert. 

A specific letter for patients can be found in the attachments below.

No further supplies of Emerade will be available on the UK market until the issue has been resolved, therefore patients and carers should be appropriately trained to use other brands.

Patients are being advised to follow current Coronavirus (COVID-19) guidance in relation to self-isolation, social distancing and shielding, using telephone communication and delivery services where possible, https://www.gov.uk/coronavirus.

Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.



Additional information: NHS England Regional Offices; please cascade this alert to any Community Pharmacy, Dentists, Optometrists and GP Practices not yet registered with CAS.

Alert reference: EL (20)A/23

Attachments:
Cascade to:
  • #GP#
  • #ACCIDENTEMERGENCY#
  • #COMMUNITYPHARMACISTS#
  • #DENTISTS#
  • #DISPENSING GP#
  • #OPTOMETRISTS#
  • #NURSES#
  • #HospitalPharmacy#


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency