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Medicines defect noticeMHRA

Hartmann's Solution for Injection BP as Steriflex No. 11 or freeflex defect notice over a packaging defect

Packaging or device defectLow riskClass 4

Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex.

Check your product

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

10 identifiers listed for this notice.

  • Hartmann's Solution for Injection BP as Steriflex No. 11 or freeflex 20 x 500 ml

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 14TB7322
    • 14TD7312
    • 14TE7326
    Product licenceThe PL number on the carton.
    • PL 08828/0083
    ExpiryOn the carton, blister or label.
    • 18/02/2027
    • 02/04/2027
    • 20/05/2027
    First distributedOn the product, its label or its packaging.
    • 13/04/2024
    • 09/07/2024
    • Not yet distributed

What to do now

The problem with Hartmann's Solution for Injection BP as Steriflex No. 11 or freeflex 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/31). Quoted as issued.

Summary

Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex.

The risk

DMRC reference number DMRC 31178038 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 supplying and when administering the product.

Fresenius Kabi Limited has confirmed that all production of future batches will contain the correct calcium content stated on the infusion bag. However, batch 14TE7326, which has yet to be distributed, will not be repackaged to avoid any supply concerns.

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 Hartmann's Solution for Injection BP as Steriflex No. 11 or freeflex been recalled?

The problem with Hartmann's Solution for Injection BP as Steriflex No. 11 or freeflex 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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