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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 04-Mar-2020 13:59:18

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • Ofsted recipients
  • Social Care Providers (registered with CAS)
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Director of Public Health
  • 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 150 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Broadcast content: Pharmaswiss ńĆeska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 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 150mcg pens, to inform them of the recall information contained within this alert. Additional advice has also been provided for patients with Emerade 300mcg pens and Emerade 500mcg pens, which are not currently subject to a recall due to insufficient supplies of alternative brands of pens. 

Specific letters 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.

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 Community Pharmacy, Dentists, Optometrists and any GP Practices not yet registered with CAS.


Alert reference: EL (20)A/14

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency