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
| 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: [email protected]
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.
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