AN urgent warning has been issued for a common inhaler used by asthma sufferers due to a mistake on the labelling.
The error affecting Flutiform 250 micrograms inhalers means asthma patients could be informed of the wrong dose of the drug.
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Patients have been advised to continue to take the medication as prescribed by their healthcare professionalsCredit: Getty
In its alert, UK medicines regulator, the MHRA said: “CD Pharma Ltd [the inhaler’s manufacturer] have notified the MHRA of an error on the outer carton of the product for the batches listed in this notification.
“While the total active content statement is correct, the delivered dose content statement is incorrect.”
The other product details on the inhaler carton, however, including the name, strength and pharmaceutical form of the medicine, are correct.
And the quality of the medicine has not been impacted by the labelling defect.
Patients have been advised to continue to take the medication as prescribed by their healthcare professionals.
Meanwhile, healthcare professionals have been advised to stop supplying the above batch immediately.
The recall urged: “Quarantine all stock and return it to your supplier using your supplier’s approved process.”
The MHRA said: “This is a wholesale and pharmacy level recall that will be actioned by a healthcare professional.
“There is no quality issue with the product and patients can continue to take their medicine as prescribed.”
The labelling mistake means patients may have thought they were only receiving half the necessary dose of the medication.
Early Warning Signs of an Asthma Attack
As part of the recall, patients who do experience adverse reactions or have any questions about the medication are advised to seek medical attention.
Any suspected adverse reactions should also be reported via the MHRA Yellow Card Scheme.
Asthma is a common condition. In the UK, 7.2 million people have asthma. This is about eight in every 100 people, according to Asthma + Lung UK.
Medicine details
Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension
PL: 20492/0724
Active Ingredient: fluticasone propionate/formoterol fumarate
SNOMED code: n/a
GTIN: 05060011835409
Affected lot batch numbers:
270185-24062FA-30424 – expiry date 30th June 2026 – pack size 120 Actuations – first distributed 30 Jun 2025
270186-24065FA-30443 – expiry date 30 Jun 2026 – pack size 120 Actuations – first distributed 04 Jul 2025
270774-24082FB-30444 – expiry date 31 Jul 2026 – pack size 120 Actuations – first distributed 04 Jul 2025
269881-24064FA-30425 – expiry date 30 Jun 2026 – pack size 120 Actuations – first distributed 04 Jul 2025
It affects the airways that carry air in and out of your lungs, causing them to become inflamed.
This makes the airways narrower so less air gets into and out of the lungs.
Symptoms, like wheezing, breathlessness, a cough or a tight chest, can be triggered by things like exercise, allergens or changes in weather.
At the moment there is no cure for asthma, but most people with asthma can control their symptoms well with asthma inhalers.
Depending on how severe your symptoms are, the NHS says you may be offered either:
- an inhaler to use only when you get symptoms – this is called an anti-inflammatory reliever (AIR) inhaler
- an inhaler to use every day to help prevent symptoms, as well as when you get symptoms – this is called a maintenance and reliever therapy (MART) inhaler
- two separate inhalers – a preventer inhaler to use every day to help prevent symptoms, and a blue reliever inhaler to use when you get symptoms (you should not be given a blue reliever inhaler to use on its own)
The NHS also advises: “It’s important to use your inhaler correctly so that your medicine works properly.
“There are different types, including dry powder inhalers, pMDIs and soft mist inhalers.
“A doctor, nurse or pharmacist will show you how to use yours.”