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Medicines recallMHRA

Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) recalled over possible contamination

Contamination or sterilityHigh riskClass 2

medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests.

Check your product

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

6 identifiers listed for this notice.

  • Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) 1

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • G220393B
    • G220393C
    Product licenceThe PL number on the carton.
    • PL 11587/0005
    ExpiryOn the carton, blister or label.
    • 30/06/2025
    First distributedOn the product, its label or its packaging.
    • 12/10/2022
    • 30/03/2023

What to do now

Affected batches of Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) may be contaminated, for example with particles or microorganisms.

  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. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

Symptoms and when to get help

Look out for

  • redness, swelling or pain where the product was used
  • a high temperature

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(23)A/26). Quoted as issued.

Summary

medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests.

The risk

MDR number MDR 009-06/23 Company name

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact 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

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact 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 Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) been recalled?

Affected batches of Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) may be contaminated, for example with particles or microorganisms. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

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?

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.

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