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Originator: National Patient Safety Alert - MHRA

Issue date: 16-Jun-2021 11:16:56

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • NHS Regional Offices
  • 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)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Social Care Providers (registered with CAS)
  • 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
  • DHSC Supply Disruption - Medicines
  • Community Pharmacy
  • Primary Care Networks
  • GP Practices 1

Action category: Action

Title: Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd due to precautionary risk of causing overdose

Broadcast content:

Zentiva Pharma UK Limited have notified the MHRA of an issue related to the homogeneity of a batch of Co-codamol 30/500 Effervescent Tablets that could result in a potential underdose and lack of efficacy or an overdose.

Active Pharmaceutical Ingredients:

  • ·   30mg codeine phosphate hemihydrate
  • ·   500mg paracetamol

The specific batch is being recalled as a precautionary measure due to the outcome of an ongoing investigation by the Marketing Authorisation Holder (MAH) which has concluded that there is the potential for some tablets to have too little active ingredients (codeine phosphate and paracetamol) in them and some tablets to contain too much active ingredients.

This alert is for action by: primary and secondary care, specifically those involved in pharmacy services, including dispensing general practices.

Additional information: NHS England and NHS Improvement regional teams: please cascade this alert to community pharmacy contractors

Alert reference: NatPSA/2021/004/MHRA

Action underway deadline: 16-Jun-2021

Action complete deadline: 21-Jun-2021


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency