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MHRA issues recall of Ventolin and Seretide batches

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a patient level drug alert recalling two specific batches of GSK’s Ventolin Accuhaler due to a manufacturing issue that results in a small number of devices not delivering the full number of doses.

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 MHRA has stressed that other asthma inhalers, including the more commonly used Ventolin Evohaler, are not affected by these issues.

Bernadette Sinclair Jenkins, MHRA’s 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 their dispensing practice and speak to a pharmacist who will provide a replacement.

The MRHA is strongly encouraging people to report any issues with inhalers via the Yellow Card Scheme. Information is available to healthcare professionals by contacting GSK’s Customer Support Team via customercontactuk@gsk.com or calling on 0800 221 441.

The affected products are:  

  • Ventolin Accuhaler 200mcg 1x60D; Batch number 786G; Expiry date 05/2019
  • Ventolin Accuhaler 200mcg 1x60D; Batch number 754P; Expiry date 05/2019
  • Seretide Accuhaler 50/250mcg 1x60D; Batch number 5K8W; Expiry date 04/2019

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