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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 12-Feb-2020 13:00:40

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
  • Dispensing GP Practices
  • GP Practices
  • DHSC Supply Disruption - Medicines
  • Primary Care Networks

Action category: Class 3: Action within 5 days

Title: CLASS 3 FMD DRUG ALERT, ACTION WITHIN 5 DAYS, GLAXO WELLCOME UK LTD T/A GSK, BECONASE AQUEOUS NASAL SPRAY

Broadcast content:

Glaxo Wellcome UK Ltd T/A GSK has informed us of an issue related to error in the decommissioning of a specific batch of Beconase Aqueous Nasal Spray. Upon decommissioning at the pharmacy and when scanning the serialised 2D code, the status of packs may report as ‘DESTROYED.’ Although there is no risk to product quality, any remaining stock should be quarantined and returned.

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: This alert is relevant to Dispensing GP Practices.


Alert reference: EL (20)A/07

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency