Class 4 Medicines Defect Information: SmofKabiven extra Nitrogen Electrolyte Free, EL (20)A/39, PL 08828/0269

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 PL 08828/0269.

MDR Number

MDR 062-08/20

Company Name

Fresenius Kabi Ltd & Calea UK Ltd

Product description

SmofKabiven extra nitrogen electrolyte free, emulsion for infusion

Product Code Batch Number Expiry Date Bag Size First Distributed
833004220 10NI3300 31 Aug 2021 1518ml 05 May 2020
833012220 10PB8836 31 Jan 2022 2025ml 10 Aug 2020

Brief description of the problem

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 PL 08828/0269. A sentence has been inadvertently included stating “with electrolytes” on an electrolyte free product. The outer cartons and leaflets have been checked and these 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.

Further Information

For more information or medical information queries, please contact: Medical.Information-UK@fresenius-kabi.com

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

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EL (20)A39

Updates to this page

Published 13 August 2020