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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 28-Nov-2019 13:59:51

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
  • Regional Directors of Public Health

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • DHSC Supply Disruption - Medicines

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, CESKA REPUBLIKA S.R.O. (AN AFFILIATE OF BAUSCH AND LOMB UK LIMITED), EMERADE 150 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE; EMERADE 300 MICROGRAM SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE AND EMERADE 500 MICROGRAM 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 the above product due to an error in one component of the autoinjector believed to cause some pens to fail to activate and deliver adrenaline. More information is provided in the attached alert. 

It is important to note that while Emerade stock held by patients is not being recalled, patients and caregivers in possession of Emerade pens need to be informed of updated safety information about the risk of failure to activate.

Healthcare professionals (GP Practices, Pharmacies) should, where possible, contact patients and carers with Emerade pens, to inform them of the additional advice contained within this alert. Additionally, 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 pharmacies.
GP Practices: Please share this alert within your practice to assist the management of patients who use these medicines.
The alert is relevant to GP Dispensing Practices.


Alert reference: EL (19)A/39

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency