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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