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Medicines defect noticeMHRA

Co-trimoxazole 80mg/400mg per 5ml adult suspension defect notice over a packaging defect

Packaging or device defectLow riskClass 4

Aspen Pharma Trading Limited has informed the MHRA that an error has been found in the Patient Information Leaflet.

Check your product

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

55 identifiers listed for this notice.

  • Co-trimoxazole 80mg/400mg per 5ml adult suspension 100ml

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • B18324E
    • B99324E
    • B05924E
    • B98724E
    • B95224A
    • B95324A
    • B22823GA
    • B85623F
    • B01923C
    • B55023B
    • B55323B
    • B97222L
    • B27922I
    • B60922G
    • B02122E
    • B71922D
    • B40821K
    • B82321F
    • B77321F
    • B21921D
    • B96420I
    • B71220H
    Product licenceThe PL number on the carton.
    • PL 39699/0038
    ExpiryOn the carton, blister or label.
    • 31st May 2028
    • 31st January 2028
    • 31st July 2027
    • 30th June 2027
    • 31st March 2027
    • 28th February 2027
    • 31st December 2026
    • 30th September 2026
    • 31st July 2026
    • 31st May 2026
    • 30th April 2026
    • 30th November 2025
    • 30th June 2025
    • 30th April 2025
    • 30th September 2024
    • 31st August 2024
    First distributedOn the product, its label or its packaging.
    • July 2024
    • April 2024
    • September 2023
    • July 2023
    • May 2023
    • March 2023
    • January 2023
    • November 2022
    • August 2022
    • June 2022
    • May 2022
    • February 2022
    • July 2021
    • May 2021
    • November 2020
    • September 2020

What to do now

Some packs of Co-trimoxazole 80mg/400mg per 5ml adult suspension have a defect that could affect how the medicine is given.

  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. 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

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.

An affected pack bought over the counter can be returned to where you bought it.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/32). Quoted as issued.

Summary

Aspen Pharma Trading Limited has informed the MHRA that an error has been found in the Patient Information Leaflet.

The risk

MDR number MDR 063-03/24 Company name

Advice for healthcare professionals

Please continue to use the product as normal but be aware of the typographical error highlighted above.

No further action is required by 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. 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. 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. 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 Co-trimoxazole 80mg/400mg per 5ml adult suspension been recalled?

Some packs of Co-trimoxazole 80mg/400mg per 5ml adult suspension have a defect that could affect how the medicine is given. 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?

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?

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.

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