View Alert
Versions:


Originator: MHRA Drug Alerts

 
From: Sze Mun Tan

Issue date: Originally issued on 23-Jul-2020 11:29:28. This version was issued on 23-Jul-2020 11:29:33

Action by recipients:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

Information to recipients:
  • 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
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4, DRUG ALERT, FOR INFORMATION, PFIZER LIMITED, ECALTA 100MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Broadcast content: Pfizer Limited has informed us that the packs of the affected batches have not been packaged with the current version of the Patient Information Leaflet containing updated storage instructions of the infusion solution in Section 5.

Advice for healthcare professionals:

When dispensing this medicine from the affected batches listed, please ensure that the correct PIL is issued. The correct PIL is available from the electronic medicines compendium (EMC) website by clicking on the link below:


The Summary of Product Characteristics (SmPC Section 6.3) has been updated to state "The infusion solution may be stored at 25oC for 48 hours. Do not freeze."

The updated SmPC is available on the EMC website: www.medicines.org.uk 

Full details of the drug alert are included in the attached PDF file. Please forward to the 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 Pharmacy contractors.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/32

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency