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.