Central Alerting System
View Alert


Originator: MHRA Drug Alerts

From: Sze Mun Tan

Issue date: 14-Dec-2020 11:59:39

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

  • 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
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • Dispensing GP Practices
  • DHSC Supply Disruption - Medicines
  • Community Pharmacy
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, PERINDOPRIL ERBUMINE 2MG, 4MG, 8MG TABLETS, PL 04569/1348, PL 04569/1349, PL 04569/1350, GENERICS (UK) LIMITED T/A MYLAN

Broadcast content: Generics (UK) Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs of batches listed is missing relevant important safety information. Please refer to the alert for details of the missing text.

Advice for healthcare professional:
When dispensing the listed batches, please check the Marketing Authorisation Holder and if any of the batches of the product listed are being dispensed, ensure that patients are aware of any missing information. Generics (UK) Limited t/a Mylan have stopped distribution of all affected batches, therefore stock received from January 2021 from wholesalers should be compliant with the new leaflet.

Full details of the drug alert are 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: NHS England and NHS Improvement Regional Offices: Please cascade this alert to Community Pharmacies
GP Practices: Please note this alert is for Dispensing GP Practices only


Alert reference: EL (20)A/58

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency