GSK is recalling two specific batches of Ventolin (salbutamol) 200mcg Accuhaler devices from patients and one specific batch of Seretide (salmeterol xinafoate, fluticasone propionate) 50/250mcg Accuhaler devices from hospitals, pharmacies, dispensing practices, retailers and wholesalers.
This action follows a manufacturing issue that may result in a small number of Accuhaler devices not delivering the full number of doses in the device.
The Accuhaler, which has a distinctive disk-like shape, is used to treat asthma, but is not widely used in the UK compared to the more commonly used Evohaler
Guidance to help patients identify if their Ventolin Accuhaler is affected by this recall and how to obtain a replacement is provided below and at www.GSK.co.uk. Prescribers and pharmacies in the UK have been notified of the recall.
No other GSK inhalers are affected by this issue and it is important to note, the more commonly used ‘boot’-shaped Ventolin Evohaler ‘rescue’ inhaler is not affected by this recall.
Dr Karen Mullen, UK Medical Director, GSK, said: “It is very easy to check whether a Ventolin Accuhaler device has come from an affected batch by checking the Lot number. Any patient who has an affected inhaler should return their inhalers to their pharmacist or dispensing practice where they will be issued with a replacement inhaler. This isn’t something we want patients to be alarmed about but it is important that we ensure our inhalers work properly for all our patients. We are committed to supplying high-quality products to our patients and sincerely regret any concern caused to them and healthcare professionals.”
Guidance for patients:
- Ventolin Accuhaler is used as a rescue medication for patients with asthma. We ask patients with Ventolin Accuhaler to check the Lot details on their device. The two Lots being recalled are: 786G and 754P. The Lot number appears on the bottom of the Ventolin Accuhaler cardboard package (four characters after the word ‘Lot’) or in the centre of the device (similarly four characters after the word ‘Lot’). Ventolin Accuhalers carrying these Lot numbers should be returned immediately to their pharmacy or dispensing practice. Patients will be issued with a replacement Ventolin Accuhaler straight away. There is no need for patients to have a prescription or visit their GP in order to be given a replacement Ventolin Accuhaler by their pharmacist.
- Seretide Accuhaler is a maintenance medication for patients with asthma. GSK has recalled one Lot of Seretide Accuhaler devices from hospitals, pharmacies, dispensing practices, retailers and wholesalers. The recalled Lot number is 5K8W. This Lot is subject to a pharmacy level recall. The recall of Seretide Accuhaler is not a patient level recall so you do not need to return your device.Patients should not stop taking their medication. However, as with any medication, if you have any concerns or are experiencing a worsening of your symptoms you should seek medical treatment. The issue should also be reported to GSK by emailing uksafety@gsk.com or calling 0800 221 441 (option 3).
- No other GSK inhalers are affected by this issue and it is important to note, the more commonly used Ventolin Evohaler is not affected by this recall.
Guidance for Healthcare Professionals
- Notification has been sent to healthcare professionals in the UK from the MHRA [https://www.gov.uk/drug-device-alerts] and GSK providing guidance on both recalls.
- A full statement will be available on our website: www.GSK.co.uk. Information is also available to patients and healthcare professionals by contacting our Customer Support Team via customercontactuk@gsk.com, via our Live Chat (https://hcp.gsk.co.uk/contact-us/live-chat.html) facility or calling on 0800 221 441 (option 4).