Inhalers have been urgently recalled after a major labelling error was discovered on several batches
A medication used to manage severe asthma has been recalled by the MHRA(Image: Getty Images)
The UK’s drug watchdog has issued an urgent recall of a widely prescribed asthma inhaler following the discovery of a serious labelling error.
The Medicines and Healthcare products Regulatory Agency (MHRA) has said that Flutiform 250 microgram inhalers are being withdrawn from pharmacies and wholesalers across the UK.
The recall follows an alert from manufacturer CD Pharma Ltd about labelling errors on external packaging.
The error affects only printed information on cartons, not the inhaler contents themselves. While the overall active ingredient content printed on the box is accurate, the delivered dose content statement is wrong, which could give users the impression they are receiving only half their prescribed dose.
Patients have been advised by the MHRA to continue to take the medicine as advised by their doctor and not to return or stop taking the product.
Patients have been told to use their asthma medication as normal(Image: PA)
The MHRA said in a statement: “Patients who are taking Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension should continue to take the medication as prescribed by their healthcare professional.
“This issue only impacts the statement related to the delivered dose and the other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct.
“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.
“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.”
Flutiform is used to manage severe asthma, a chronic respiratory condition that affects around 7.2 million people in the UK. Asthma attacks – a sudden worsening of asthma symptoms – kill, on average, three people in Britain every day.
Symptoms include wheezing, coughing, breathlessness or a tight chest. The NHS says they may be worse at night and early in the morning.
According to the Electronic Medicines Compendium (eMC), Flutiform inhalers contain two active ingredients: One which belongs to a group of medicines called steroids that help to reduce swelling and inflammation in the lungs, and another that is a type of long-acting bronchodilator, which help the lungs’ airways to stay open.