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Asthma inhaler batches recalled due to dose delivery problem

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Three specific lots of asthma inhalers are being recalled, including preventer and emergency relief inhalers, the Medicines and Healthcare products Regulatory Agency has warned.

On Wednesday, the MHRA issued a patient level drug alert recalling two specific lots of asthma inhaler manufactured by Glaxo Wellcome UK.

“It is important people check whether they have an affected inhaler”

Bernadette Sinclair Jenkins

The recall refers to two specific batches of Ventolin (salbutamol) 200mcg Accuhaler devices and one specific batch of Seretide (salmeterol xinafoate, fluticasone propionate) 50/250mcg Accuhaler.

The affected lots are numbered 786G, 754P and 5K8W. The Lot number appears on the bottom of the cardboard package or in the centre of the device.

GSK said the recall had been ordered because of a manufacturing issue that had caused a small number of the devices to not deliver the full number of doses.

As a result, the MHRA noted that patients who have used the affected batches of Ventolin may find that their symptoms were not relieved as normal by their Ventolin Accuhaler.

GSK highlighted that the Accuhaler had a “distinctive disk-like shape” but was not widely used in the UK compared to the company’s more commonly used Evohaler.

Affected Ventolin devices should be returned to a pharmacist. Meanwhile, the Seretide Accuhaler is being recalled from hospitals, pharmacies, dispensing practices, retailers and wholesalers.

Asthma

Aeretide Accuhaler

Source: MHRA

Seretide (salmeterol xinafoate, fluticasone propionate) 50/250mcg Accuhaler

Only a small proportion of the units are defective. Other asthma inhalers, including the more commonly used Ventolin Evohaler, are not affected, noted both the MHRA and GSK.

Bernadette Sinclair Jenkins, regulatory assessment manager of the MHRA’s inspections, enforcement and standards unit, said: “It is important people check whether they have an affected inhaler.

“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,” she said.

Dr Karen Mullen, GSK’s UK medical director, added: “We are committed to supplying high-quality products to our patients and sincerely regret any concern caused to them and healthcare professionals.”

Details of the affected inhaler batches

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

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