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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 13-Aug-2020 12:59:51

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
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, FRESENIUS KABI LTD/CALEA UK LTD, SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE EMULSION FOR INFUSION, PL 08828/0269

Broadcast content:

Fresenius Kabi Ltd/Calea UK Ltd has informed us of an error on the bag labels for SmofKabiven extra nitrogen electrolyte free, emulsion for infusion. A sentence has been inadvertently included stating "with electrolytes" on an electrolyte free product. The outer cartons and leaflets have been checked and there are all in compliance. The bag label should state "1. Amino acid solution".

Advice for healthcare professionals

  • This alert is for information only. There are no concerns with the product quality, safety or efficacy and therefore the product is not being recalled. Healthcare professionals should be aware that there is a product available with electrolytes and caution should be exercised when dispensing and administering this product.

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.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/39

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency