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Originator: MHRA Drug Alerts

From: Alison Bunce - Medicines and Healthcare Products Regulatory Agency

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

This alert has been issued to:
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • 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

  • 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

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

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency