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Originator: MHRA Drug Alerts

From: Alison Bunce - Medicines and Healthcare Products Regulatory Agency

Issue date: 03-Jan-2019 12:30:02

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 2: Action within 48 hours

Title: DRUG ALERT CLASS 2, ACTION WITHIN 48 HOURS, ACTAVIS GROUP PTC EHF, IRBESARTAN /HYDROCHLOROTHIAZIDE 300 / 12.5MG FILM-COATED TABLETS; IRBESARTAN / HYDROCHLOROTHIAZIDE 150 / 12.5MG FILM-COATED TABLETS.

Broadcast content:

Recall of affected batches due to potential contamination with Nnitrosodiethylamine (NDEA).

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 (19)A/01

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency