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Originator: National Patient Safety Alert - MHRA

Issue date: 21-Oct-2022 11:02:33

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Regional Offices
  • Special Health Authorities
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Community Pharmacy
  • Primary Care Networks
  • GP Practices 1

Action category: Action

Title: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sonofi, due to the presence of bacterial endotoxins

Broadcast content:

Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2).

This is due to out of specification results obtained for bacterial endotoxins, which has been confirmed through testing of retain samples. This issue was observed following a medical adverse event, which reported that four patients experienced high grade of fever approximately three hours post-administration of vials from the impacted batches.

Due to the out of specification results observed there is a potential life threatening or serious risk to patient health.

This National Patient Safety Alert contains further information and actions for providers.

Additional information: NHS England Regional Teams: please cascade this alert to Community Pharmacy contractors

Alert reference: NatPSA/2022/008/MHRA

Action underway deadline: 24-Oct-2022

Action complete deadline: 26-Oct-2022


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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency