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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 08-Jun-2020 12:59:36

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)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • 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
  • Dispensing GP Practices
  • 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, TORBAY PHARMACEUTICALS (FOR VERITON PHARMA LTD), EPISTATUS (MIDAZOLAM) 10MG/ML OROMUCOSAL SOLUTION - MULTI DOSE BOTTLES, (UNLICENSED)

Broadcast content: Torbay Pharmaceuticals has informed us that the child-resistant container closure for Epistatus 10mg/mL Oromucosal Solution (Multi Dose Bottles) may be faulty and incorrectly engaged. The child-resistant closure can potentially be removed without unscrewing the cap closure. Healthcare professionals are advised to stop supplying the specific batches of the product immediately and quarantine all remaining stock and return it to your supplier using your supplier’s approved process. 

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 and any Dispensing GP Practice yet to be registered with CAS.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/25

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency