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Originator: National Patient Safety Alert - MHRA

Issue date: Originally issued on 04-Aug-2022 11:34:29. This version was issued on 04-Aug-2022 11:34:29

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 Mexiletine hydrochloride 50mg, 100mg and 200mg Hard Capsules, Clinigen Healthcare Ltd due to a potential of underdosing and/or overdosing

Broadcast content:
***04/08/2022. Per correction by Clinigen Healthcare Ltd, an update was made to correct the expiry date for Mexiletine hydrochloride 50mg Hard Capsules (batch 2111216)****

Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.

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/2022/007/MHRA

Action underway deadline: 08-Aug-2022

Action complete deadline: 12-Aug-2022


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency