Class 4 Medicines Defect Information: SmofKabiven Central emulsion for Infusion, Fresenius Kabi Ltd, EL (21)A/37

Source: MHRA Gov.uk

Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.

MDR Number

MDR 022-12/21

Company name

Fresenius Kabi Limited

Product description

SmofKabiven Central emulsion for Infusion

Batch Number Expiry Date Pack Size First Distributed
10PK7682 30 Sep 2022 4 x 986 ml 3-chamber infusion bag 01 Dec 2020
10PL9065 31 Oct 2022 4 x 986 ml 3-chamber infusion bag 22 Dec 2020
10QA9950 31 Dec 2022 4 x 986 ml 3-chamber infusion bag 22 Feb 2021
10QC4068 28 Feb 2023 4 x 986 ml 3-chamber infusion bag 21 May 2021
10QG7923 30 Jun 2023 4 x 986 ml 3-chamber infusion bag 28 Aug 2021
10QI9859 31 Aug 2023 4 x 986 ml 3-chamber infusion bag 19 Oct 2021
10QL2802 31 Oct 2023 4 x 986 ml 3-chamber infusion bag Not distributed yet

Active Pharmaceutical Ingredient: Alanine, arginine, glycine, histidine, isoleucine, leucine, lysine (as acetate), methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride (as dihydrate), sodium glycerophosphate (as hydrate), magnesium sulphate (as heptahydrate) potassium chloride, sodium acetate (as trihydrate), zinc sulphate (as heptahydrate), glucose (as monohydrate), soya-bean oil; refined, medium-chain triglycerides, olive oil; refined and fish oil; rich in omega-3-acids.

Brief description of the problem

Fresenius Kabi Limited have identified an error on the infusion bag packaged into the above batches. In the energy content section printed onto the bag the amount of carbohydrates (glucose anhydrous) has been incorrectly declared as 150 g, the actual amount is 125 g.

The correct amount of carbohydrates (as monohydrate) is correctly declared on the infusion bag under the ingredients section as glucose 42%: glucose (as monohydrate) 125 g. The correct amount is also stated on the outer carton and in the SmPC.

Advice for healthcare professionals

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when administering this product particularly when calculating patient nutritional requirements.

Fresenius Kabi Limited have confirmed that all future batches will contain an infusion bag with the correct declaration of carbohydrates (glucose anhydrous).

Further Information

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

Recipients of this Medicines Notification 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.

Download the document

EL (21)A 37 Final

 

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