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Medicines recallMHRA

Trimbow 87/5/9 mcg pressurised inhalation solution recalled over a strength or dose problem

Wrong strength or doseMedium riskClass 3

Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stability testing.

Check your product

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

7 identifiers listed for this notice.

  • Trimbow 87/5/9 mcg pressurised inhalation solution 1 container with 120 actuations

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 1165031
    • 1150215
    Product licenceThe PL number on the carton.
    • PLGB 08829/0193
    ExpiryOn the carton, blister or label.
    • 18/09/2024
    • 25/12/2023
    First distributedOn the product, its label or its packaging.
    • 19/01/2023
    • 27/04/2022

What to do now

The problem with Trimbow 87/5/9 mcg pressurised inhalation solution is strength: the dose in the affected batches may be higher or lower than the label says.

  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 medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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(23)A/36). Quoted as issued.

Summary

Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stability testing.

The risk

MDR number MDR 148-09/23 Company name

Advice for healthcare professionals

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

No further action is required by patients, these batches are being recalled at the pharmacy and wholesale level as a precautionary measure. Chiesi Ltd has investigated the issue and its medical assessment has shown that the product remains beneficial to patients. Patients should continue to take 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

No further action is required by patients, these batches are being recalled at the pharmacy and wholesale level as a precautionary measure. Chiesi Ltd has investigated the issue and its medical assessment has shown that the product remains beneficial to patients. Patients should continue to take 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 Trimbow 87/5/9 mcg pressurised inhalation solution been recalled?

The problem with Trimbow 87/5/9 mcg pressurised inhalation solution is strength: the dose in the affected batches may be higher or lower than the label says. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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?

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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