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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 25-Oct-2019 12:08:28

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
  • DHSC Supply Disruption - Medicines

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, OMEGA PHARMA LIMITED TRADING AS PERRIGO, ZANTAC 75 TABLETS, ZANTAC 75 RELIEF TABLETS AND GALPHARM INTERNATIONAL LIMITED (PART OF THE PERRIGO GROUP), RANITIDINE 75MG TABLETS (VARIOUS LIVERIES)

Broadcast content:
Omega Pharma Limited and Galpharm International Limited are recalling all unexpired stock of Ranitidine Tablets (various liveries) from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

This alert is the second alert, out of two, related to ranitidine products issued today (25 October 2019). This has been issued as a separate alert as it relates to particular ranitidine products that can be supplied without a prescription. 

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 practice to assist the management of patients who use these medicines.
NHS England Regional Offices: Please cascade this alert to community pharmacies.


Alert reference: EL (19)A/30

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency