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Originator: National Patient Safety Alert - MHRA

Issue date: 10-Nov-2022 13:10:38

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
  • 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
  • Regional Directors of Public Health
  • Director of Public Health
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Community Pharmacy
  • Primary Care Networks
  • GP Practices 1

Action category: Action

Title: Prenoxad 1mg/ml Solution for Injection in a pre-filled syringe, Macarthys Laboratories, (Aurum Pharmaceuticals Ltd), caution due to potential needles in sealed kits

Broadcast content:

Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA that a limited number of Prenoxad kits (packs) in a batch marketed in France have missing needles. 

Although no reports of UK marketed kits with missing needles have been received to date, the potential for kits to contain fewer than two (2) needles in all distributed batches (see page 2) cannot be excluded based on the investigation by the company. However, due to the critical need for this product, the specified batches are not being recalled. 

Prenoxad kits are packed with two (2) Terumo 23 gauge 1ΒΌ inch needles, along with the pre-filled syringe containing the active ingredient (naloxone  hydrochloride), and a Patient Information Leaflet. 

Naloxone is a drug that reverses the effects of an opioid overdose. If no needles are present in the kit, there is a risk that patients, members of the public and/or healthcare professionals may not be able to administer life-saving doses of naloxone from these kits in an emergency. This may impede the treatment for a patient with an opioid overdose, which may result in delay to intervention and possible death.

Healthcare professionals and service providers should note the actions required before supplying Prenoxad kits. 

We ask providers to contact individuals supplied with Prenoxad kits where possible and support checks to ensure kits contain two (2) needles in each kit. Support should be provided to individuals with kits who are unsure how to check their kits. See page 2 and supplementary information.

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.

Directors of Public Health are asked to cascade this to commissioners and providers of drug treatments and prevention services and other relevant services that have, or may have, contact with drug users including: sexual health services; youth services; hostels' relevant information networks; and service user groups.

Could CCGs/ICBs support in ensuring this is cascaded to prison pharmacy teams.

To avoid any doubt, this alert must be actioned by Ambulance Trusts

Alert reference: NatPSA/2022/009/MHRA

Action underway deadline: 10-Nov-2022

Action complete deadline: 17-Nov-2022


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency