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Originator: MHRA Drug Alerts

From: Catherine Pitt

Issue date: 10-Jul-2018 16:42:58

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 TABLETS, VALSARTAN/HYDROCHLOROTHIAZIDE 160/12.5MG TABLETS

Broadcast content: The Drug Alert EL (18)A/11 issued on 5 July 2018 is now superseded by this revised alert EL (18)A/11 – revision 1 because Actavis (now Accord) has provided new information that an additional product (Valsartan/Hydrochlorothiazide 160/12.5mg Film-Coated Tablets) is also affected and is being recalled. Accord apologises for any inconvenience this may cause. 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 - revision 1

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


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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency