Batch BeaconUK recalls and safety alerts

Medicines defect noticeMHRA

suspension defect notice over a strength or dose problem

Wrong strength or doseLow riskClass 4

Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, batch 77518.

Check your product

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

3 identifiers listed for this notice.

  • suspension 120 dose

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 77518
    ExpiryOn the carton, blister or label.
    • 12/2025
    First distributedOn the product, its label or its packaging.
    • 06/01/2025

What to do now

Suspension has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves.

  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 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

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(25)A/12). Quoted as issued.

Summary

Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, batch 77518.

The risk

DMRC reference number 34709021 Marketing Authorisation Holder

Advice for healthcare professionals

Healthcare Professionals are advised that if a unit is identified with this printing defect:

The quality and efficacy of the medicinal product is not impacted by this defect and can continue to be prescribed, dispensed and used, as appropriate.

The printing defect is restricted to the outer label shown in the image in this notification, all other labels and Patient Information Leaflet contain no printing defects and are compliant to PLPI 20504/0109.

Reassure any concerned patients that this is a labelling defect only and that the product is Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension. Where necessary show them other labels or the Patient Information Leaflet that do not contain this error.

Patients should continue to take medicines from the impacted units of batch 77518 as prescribed by your healthcare professional as the defect is restricted to the specific defect shown on the image in this notification.

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

Patients should continue to take medicines from the impacted units of batch 77518 as prescribed by your healthcare professional as the defect is restricted to the specific defect shown on the image in this notification.

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 suspension been recalled?

Suspension has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves. 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, 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?

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.

Related notices