View Alert
Originator: MHRA Drug Alerts

From: Alison Bunce - Medicines and Healthcare Products Regulatory Agency

Issue date: 05-Jul-2018 16:01:01

Action by recipients:
  • NHS Trusts (England) - Medical Director
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Regional Offices

Information to recipients:
  • Director of Public Health
  • NHS Foundation Trusts (England) - Chief Executive
  • NHS Trusts (England) - Chief Executive
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Clinical Commissioning Groups

Action category: Class 1: Immediate

Title: DRUG ALERT CLASS 1, IMMEDIATE ACTION, DEXCEL PHARMA LIMITED, VALSARTAN 40MG, 80MG and 160MG CAPSULES; ACTAVIS GROUP PTC EHF, VALSARTAN 40MG, 80MG, 160MG AND 320MG FILM COATED TABLETS

Broadcast content: All batches of the above are being recalled at a European level 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 


Alert reference: EL (18)A/11

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


Contact our helpdesk

Telephone: 020 3080 6747
Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency