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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 08-Oct-2019 15:19:37

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
  • Independent Healthcare Providers (registered with CAS)
  • 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
  • GP - Locum
  • GP Practices

Action category: Class 2: Action within 48 hours

Title: DRUG ALERT CLASS 2, ACTION WITHIN 48 HOURS, GLAXOSMITHKLINE TRADING AS GLAXO WELCOME UK LTD, ZANTAC INJECTION 50MG/2ML, ZANTAC SYRUP 150MG/10ML, ZANTAC TABLETS 150MG, ZANTAC TABLETS 300MG

Broadcast content:
GlaxoSmithKline is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicine (POM) from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Full details of the drug 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


Additional information: GP Practices: please share this alert within your practices to assist the management of patients who use these medicines.
NHS England Regional Offices: please cascade this alert to community pharmacy.


Alert reference: EL (19)A/24

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency