MHRA Class 4 Medicines Notification: Sodium Chloride Intravenous Infusion 0.9% Freeflex (Fresenius Kabi Limited)

Class 4 Medicines Defect Information: Sodium Chloride Intravenous Infusion 0.9% Freeflex (Fresenius Kabi Limited)

Drug alert number: EL (24)A/10

Date issued: 21 March 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Sodium Chloride Intravenous Infusion 0.9% Freeflex (Fresenius Kabi Limited)

Company name: Fresenius Kabi Limited

Product name: Sodium Chloride Intravenous Infusion 0.9% Freeflex

SNOMED Code: 40545111000001108

Batch Number Expiry date Pack size First distributed
13SMR091 30/11/2025 50 x 100ml 19/02/2024
13SMR061 30/11/2025 50 x 100ml Not yet distributed
13TAR011 31/12/2025 50 x 100ml Not yet distributed
13SLR271 31/10/2025 50 x 100ml 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.

View full alert here.

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 Medical.Information-UK@fresenius-kabi.com or telephone +44 (0)1928533575

For stock control enquiries please contact FK.complaints-uk@fresenius-kabi.com or telephone +44 (0) 1928 533758

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