Class 4 Medicines Notification: Fresenius Kabi Limited, Sodium Chloride Intravenous Infusion 0.9% Freeflex, EL (24)A/10
Fresenius Kabi Limited has informed the MHRA of an error on the infusion bag packaged into the specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex.
MDR number
MDR 332-02/24
Company name
Fresenius Kabi Limited
Product name
Sodium Chloride Intravenous Infusion 0.9% Freeflex
SNOMED Code
40545111000001108
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 13SMR091 | 30/11/2025 | 50 x 100 ml | 19/02/2024 |
| 13SMR061 | 30/11/2025 | 50 x 100 ml | Not Yet Distributed |
| 13TAR011 | 31/12/2025 | 50 x 100 ml | Not Yet Distributed |
| 13SLR271 | 31/10/2025 | 50 x 100 ml | Not Yet Distributed |
Active Pharmaceutical Ingredient: Sodium Chloride for Injections 0.9% w/v
Brief description of the problem
Fresenius Kabi Limited has informed the MHRA of an error on the infusion bag packaged into the specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex mentioned in this notification. The error has been identified in the contents box (active substance section). It is incorrectly printed ‘Each 50 ml contains approx’; this should state ‘Each 100 ml contains approx’.
The correct quantity is stated on the outer carton and in the Summary of Product Characteristics.
Advice for healthcare professionals
The quality of the product is not impacted by this labelling error; therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when administering this product, particularly when performing electrolyte or dilution calculations.
The manufacturer has confirmed that the batches that have yet to be distributed will be accompanied by a note explaining the issue. These batches will not be repackaged to avoid any supply concerns.
Fresenius Kabi Limited has confirmed that all production of future batches will contain an infusion bag with the correct declaration of the amount of electrolytes.
Advice for patients
No action is needed from patients. Patients should continue to receive this medicine from these batches as given to you by your healthcare professional. There is no impact to product quality. Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Further Information
For more information or medical information queries please email [email protected] or telephone +44 (0)1928533575
For stock control enquiries please contact [email protected] or telephone +44 (0) 1928 533758
Recipients of this Medicines Recall 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.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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