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Medicines recallMHRA

Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules recalled over a quality concern

Medicine quality concernHigh riskClass 2

CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule containing powder and two yellow tablets.

Check your product

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

4 identifiers listed for this notice.

  • Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules 14 capsules

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 24849001
    • 24849002
    ExpiryOn the carton, blister or label.
    • 31/07/2026
    First distributedOn the product, its label or its packaging.
    • 13/12/2024

What to do now

Affected batches of Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules are subject to a recall or defect notice.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA Yellow Card scheme.

Why it matters. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

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(25)A/05). Quoted as issued.

Summary

CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule containing powder and two yellow tablets.

The risk

DMRC reference number DMRC-34425982 Medicine Details

Advice for healthcare professionals

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

Should a patient present a pack containing an extra tablet, the tablet may be removed and the patient assured that the capsule is safe to take stating the extra tablet did not come from the capsule.

If you find a pack containing an additional tablet, please take the medication to the dispensing pharmacy you obtained the medicine from. Patients may continue to take capsules from non-impacted packs as prescribed by your healthcare professional.

A small percentage of blister pockets have been found to contain an additional yellow tablet alongside the capsule, these are from the manufacturing process and not from broken capsules.

Patients that have taken the additional tablet with the capsule have ingested a higher dose of nitrofurantoin than was intended, however, the effects are understood and this should not have caused harm.

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

If you find a pack containing an additional tablet, please take the medication to the dispensing pharmacy you obtained the medicine from. Patients may continue to take capsules from non-impacted packs as prescribed by your healthcare professional.

A small percentage of blister pockets have been found to contain an additional yellow tablet alongside the capsule, these are from the manufacturing process and not from broken capsules.

Patients that have taken the additional tablet with the capsule have ingested a higher dose of nitrofurantoin than was intended, however, the effects are understood and this should not have caused harm.

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 Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules been recalled?

Affected batches of Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules are subject to a recall or defect notice. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

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?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

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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