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Originator: MHRA Drug Alerts

From: Alison Bunce - Medicines and Healthcare Products Regulatory Agency

Issue date: 27-Jun-2019 15:00:31

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
  • 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

Action category: Class 2: Action within 48 hours

Title: FALSIFIED MEDICINES DIRECTIVE ALERT CLASS 2, ACTION WITHIN 48 HOURS, B & S HEALTHCARE, MULTIPLE PARALLEL IMPORTED PRODUCTS.

Broadcast content: Recall of medicines that have been taken out of the regulated medicines supply chain during distribution and later re-introduced.  The products were parallel imported into the UK from Italy by B & S Healthcare. The products are believed to be legitimate medicines.

Full details of the FMD 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 Alert
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 Regional offices are asked to please cascade this alert to GPs for information and make it clear that this is because patients may seek advice from their GP if they have been taking any of the affected medicines.

Alert reference: EL (19)A/15

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency