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

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

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  PL 08828/0187

Details of the affected batch:

Active Pharmaceutical Ingredients: 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 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. The photograph below is of an infusion bag with the error, the yellow circle indicates the location where the carbohydrates (glucose anhydrous) are incorrectly declared and the green circle highlights where the glucose content is correctly declared.

Advice to 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).

Company contacts for further information:

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

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