Medicines recallMHRA
Class 4 Medicines Notification recalled over a packaging defect
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.
Check your product
Only products that match these details are covered. Have your pack in front of you.
9 identifiers listed for this notice.
Class 4 Medicines Notification 50 x 100 ml
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 13SMR091
- 13SMR061
- 13TAR011
- 13SLR271
- ExpiryOn the carton, blister or label.
- 30/11/2025
- 31/12/2025
- 31/10/2025
- First distributedOn the product, its label or its packaging.
- 19/02/2024
- Not Yet Distributed
What to do now
A fault with the packaging or delivery device of Class 4 Medicines Notification has been found.
- Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
- Compare the batch number printed on the box or label with the batches listed here.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- Any side effect you think is linked can be reported through the Yellow Card scheme.
Why it matters. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.
Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/10). Quoted as issued.
Summary
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.
The risk
MDR number MDR 332-02/24 Company name
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.
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.
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.
Open the MHRA notice
Questions
Why has Class 4 Medicines Notification been recalled?
A fault with the packaging or delivery device of Class 4 Medicines Notification has been found. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.
Do I need a new prescription?
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.