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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 17-Feb-2020 10:59:20

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
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 FMD DRUG ALERT, FOR INFORMATION, ACCORD HEALTHCARE LTD, DIAMORPHINE HYDROCHLORIDE BP 100MG LYOPHILISATE FOR SOLUTION FOR INJECTION

Broadcast content: Accord Healthcare Ltd has informed us of an issue related to the expiry date for the above batches, which has not been encoded in 2D data matrix. Upon FMD scanning verification and decommissioning the product. Attempts to scan to verify or to verify and decommission the FMD 2D Data Matrix code on the pack will result in an ‘Alert’ or a failed scan. Please perform the usual checks for falsified medicines according to the FMD Source guidance and dispense if deemed acceptable based on these checks. Due to inadequate supply of alternative products, the product is not being recalled. This issue only affects the batches listed above and all future batches will be corrected to avoid this error.

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.

Falsified Medicines Directive (FMD) 2011/62/EU introduced new requirements to enhance the security of the European supply chain. Where the MHRA has identified risks to the security of the supply chain, FMD Alerts will be issued. For further information about FMD and safety features, please see this link on GOV.UK.


Additional information: NHS England Regional Offices: Please cascade this alert to community pharmacy.
GP Practices: Please note this alert is relevant for Dispensing GP Practices only.


Alert reference: EL (20)A/09

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency