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Medicines defect noticeMHRA

Sodium Chloride 0.9% Intravenous Infusion BP (Freeflex and Freeflex Plus) defect notice over a packaging defect

Packaging or device defectLow riskClass 4

Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.

Check your product

Only products that match these details are covered. Have your pack in front of you.

18 identifiers listed for this notice.

  • Product 1 20 x 500 ml

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 13SKL101
    • 13TAL213
    Product licenceThe PL number on the carton.
    • PL 08828/0084
    ExpiryOn the carton, blister or label.
    • 30/09/2026
    • 31/12/2026
    First distributedOn the product, its label or its packaging.
    • 23/01/2024
    • 06/03/2024

  • Product 2 30 x 250 ml

    Batch code
    • 13SMF061
    • 13TBF281
    Expiry
    • 30/11/2026
    • 31/01/2027
    First distributed
    • Not yet distributed

  • Product 3 50 x 100 ml

    Batch code
    • 13SLF242
    • 13TAF173
    Expiry
    • 31/10/2025
    • 31/12/2025
    First distributed
    • 17/01/2024
    • 29/03/2024

What to do now

The problem with Sodium Chloride 0.9% Intravenous Infusion BP is the pack or device, such as a syringe, cap, blister or inhaler.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. 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

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/17). Quoted as issued.

Summary

Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.

The risk

MDR number MDR 035-05/24 Company name

Advice for healthcare professionals

This notification is intended to inform healthcare professionals of the discrepancy with the PIL for specific batches of product. There is no product quality nor patient safety-related implications with this issue.

Fresenius Kabi Limited have confirmed that printed copies of the correct PIL will accompany the future delivery/order of these batches.

The current approved PIL is also available on the MHRA website .

The product quality and safety are not affected by this issue. Patients should continue using medicines from these batches as prescribed by your healthcare professional.

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

The product quality and safety are not affected by this issue. Patients should continue using medicines from these batches as prescribed by your healthcare professional.

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 Sodium Chloride 0.9% Intravenous Infusion BP been recalled?

The problem with Sodium Chloride 0.9% Intravenous Infusion BP is the pack or device, such as a syringe, cap, blister or inhaler. 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, product licence, 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?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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