Full information about the Ventolin Accuhaler and Seretide Accuhaler recall – February 2018

GSK has initiated a recall of two Lots of Ventolin (salbutamol) 200mcg Accuhaler devices from patients and one Lot of Seretide (salmeterol xinafoate, fluticasone propionate) 50/250mcg Accuhaler devices from hospitals, pharmacies, dispensing practices, retailers and wholesalers.

If you use a Ventolin Accuhaler or a Seretide Accuhaler, please read the following information:

GSK has initiated a recall of two Lots of Ventolin Accuhaler devices from patients and one Lot of Seretide Accuhaler devices from hospitals, pharmacies, dispensing practices, retailers and wholesalers.

Ventolin Accuhaler is commonly used as a rescue medication for patients with asthma

Seretide Accuhaler is a maintenance medication for patients with asthma

The information on this page is provided for patients and the general public.

If you are a UK healthcare professional, notification has been sent to you from the MHRA  and GSK.

If you have questions or comments about the Ventolin Accuhaler and Seretide Accuhaler recalls, please contact our Customer Support Team customercontactuk@gsk.com, via our Live Chat facility or on 0800 221 441 (option 4).

No other GSK inhalers are affected by this issue and it is important to note, the more commonly used Ventolin Evohaler ‘rescue’ inhaler is not affected by this recall.

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. GSK is committed to supplying high-quality products to our patients and we sincerely regret any concern caused to patients and healthcare professionals. 

Why is there a product recall?

  • These recalls are taking place after we became aware of a manufacturing issue that may result in a small number of Accuhaler devices not delivering the full number of doses in the device.
  • We have carried out a thorough investigation and the root cause of the issue has been corrected.
  • Patient safety remains our absolute priority and we are taking this issue very seriously. 

Which medicines are affected?

  • We are recalling two Lots of Ventolin Accuhaler from patients, which are Lots 786G and 754P.
  • The Ventolin Accuhaler recall is being conducted because it is used as a rescue medication for patients with asthma. A defect in a rescue device could lead to a serious health risk, such as increased severity of an asthma attack (exacerbation).
  • We are recalling one Lot of Seretide Accuhaler from hospitals, pharmacies, dispensing practices, retailers and wholesalers. For Seretide Accuhaler, the Lot number being recalled is 5K8W. 
  • The Seretide Accuhaler recall is being conducted at pharmacy level because Seretide Accuhaler is a maintenance medication for patients with asthma, and in line with Seretide prescribing information, patients should be advised to have their additional fast-acting rescue medication available at all times and to seek medical help if their symptoms deteriorate.
  • No other GSK inhalers are affected by this issue and it is important to note, the more commonly used Ventolin Evohaler ‘rescue’ inhaler is not affected by this recall. 

What do patients need to do?

VENTOLIN ACCUHALER

  • Patients with Ventolin Accuhalers should check the Lot number details on their device. The two recalled Lot numbers are 786G and 754P. The Lot number appears on the bottom of the Ventolin Accuhaler cardboard package (4 characters after the word Lot) or in the centre of the device (similarly 4 characters after the word Lot). 
  • If your Ventolin Accuhaler is part of a recalled Lot, you should return your inhaler immediately to your pharmacy or dispensing practice. You will be issued with a replacement Ventolin Accuhaler straight away. There is no need for you to have a prescription or visit your GP in order to be given a replacement Ventolin Accuhaler by your pharmacist.

SERETIDE ACCUHALER

  • 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.  
  • Please do not stop taking your 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).