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People with asthma are being asked to replace specific batches of their Ventolin Accuhaler inhalers, used for the emergency relief of asthmatic symptoms. This is due to a manufacturing issue that results in a small number of the devices not delivering the full number of doses.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued a patient level drug alert recalling two specific affected lots manufactured by Glaxo Wellcome UK Limited.
Patients who have used the affected batches of Ventolin may find that their symptoms are not relieved as normal by their Ventolin Accuhaler. If this happens, they should seek medical advice. Affected Accuhalers should be returned to their pharmacist for a replacement.
Additionally, one lot of Seretide Accuhaler, used for the maintenance of preventative treatment of asthma, is being recalled from hospitals, pharmacies, dispensing practices, retailers and wholesalers in the UK.
The recall of Seretide Accuhaler is pharmacy level because this is used for maintenance treatment as opposed to a reliever treatment.
The two affected batches of Ventolin Accuhaler and the one affected batch of Seretide were distributed to the UK market.
Only a small proportion of the units are defective (images below). Other asthma inhalers, including the more commonly used Ventolin Evohaler, are not affected.
Bernadette Sinclair Jenkins, MHRAs Regulatory Assessment Unit Manager of the Inspections, Enforcement and Standards unit said:
It is important people check whether they have an affected inhaler. We want patients and their families to be confident treatment will be safe and effective when required.
People with a Ventolin Accuhaler from the affected lots should take them to their pharmacy or theirdispensing practice and speak to a pharmacist who will provide a replacement.
We strongly encourage anyone to report any issues with their inhalers or other medicines or medical devices to MHRA via our Yellow Card Scheme.
Information is also available to patients and healthcare professionals by contacting GSKs Customer Support Team via customercontactuk@gsk.com or calling on 0800 221 441 (option 4).
| Product Description | Lot details | Final market | Expiry Date |
|---|---|---|---|
| Ventolin 200mcg Accuhaler 1x60D | 786G | UK | 05/2019 |
| Ventolin 200mcg Accuhaler 1x60D | 754P | UK | 05/2019 |
| Seretide 50/250mcg - Accuhaler 1x60D | 5K8W | UK | 04/2019 |
Notes to Editor
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MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk
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Link to Drug Alert