Class 4 Medicines Defect Information: Fresenius Kabi Limited, Kabiven Emulsion for Infusion, EL (22)A/02
Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
MDR Number: MDR 117-01/22
Company name: Fresenius Kabi Limited
Product description: Kabiven Emulsion for Infusion PL 08828/0131
Details of the affected batches:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
10PC9374 |
28 Feb 2022 |
4 x 2053 ml 3-chamber infusion bag |
05 May 2020 |
|
10PE3357 |
30 Apr 2022 |
4 x 2053 ml 3-chamber infusion bag |
22 Sep 2020 |
|
10PM9641 |
30 Nov 2022 |
4 x 2053 ml 3-chamber infusion bag |
20 Apr 2021 |
|
10QA1922 |
31 Dec 2022 |
4 x 2053 ml 3-chamber infusion bag |
23 Apr 2021 |
|
10QD5451 |
31 Mar 2023 |
4 x 2053 ml 3-chamber infusion bag |
04 Oct 2021 |
Brief description of problem:
Fresenius Kabi Limited have identified an error in the infusion the infusion bag packaged into the above batches. In the list of ingredients section printed onto the bag, the amount of Glucose 19 %: Glucose (monohydrate) has been incorrectly declared as 110 g, the actual amount is 220 g.
The correct amount of carbohydrates (as glucose anhydrous) is correctly declared on the infusion bag within the energy content section as 200 g. The correct amounts are also stated on the outer carton and in the SmPC.
All other Kabiven bag sizes state the correct amount of glucose in both monohydrate and anhydrous form.
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 the amount of glucose monohydrate and equivalent glucose anhydrous.
A photograph in the full recall (see below) shows an infusion bag with the error. On the left-hand side of the photograph circled in red in the correctly declared amount of glucose anhydrous, 200 g, and on the right-hand side of the photograph also circled in red is the incorrectly declared amount of glucose monohydrate, 110 g.
Company contacts for further information:
For more information or medical information queries please contact: Medical.Information-UK@fresenius-kabi.com