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GSK recalls inhalers over manufacturing concerns


22 Feb 2018

Manufacturer GlaxoSmithKline (GSK) is recalling two batches of Ventolin Accuhaler and one batch of Seretide Accuhaler asthma inhalers due to a manufacturing issue.

GSK said that ‘a small number of Accuhaler devices may not deliver the full number of doses in the device’.

The Seretide Accuhaler has been recalled as it ‘is used for maintenance treatment as opposed to a reliever treatment’, the Medicines and Healthcare products Regulatory Agency (MHRA) added.

The MHRA said pharmacists with stock of the affected batches should:

  • Quarantine any remaining stock and return to the original supplier for credit;
  • Identify patients or carers who have received Ventolin Accuhaler 200mcg since 31st August 2017
  • Contact these patients or carers to notify them of this issue and ask them to check whether their Ventolin Accuhalers have Lot numbers 786G or 754P printed on the device and packaging; and
  • If the patient or carer has any Ventolin Accuhalers 200mcg from these lots, they should be asked to return them to their pharmacy or their dispensing practice for replacement with a different lot number. Please provide replacement packs to patients at point of return, to ensure that affected patients are not left without a supply of their medicine.

Recalled products

The affected products are:

  • Ventolin 200mcg – Accuhaler 1x60D 786G
  • Ventolin 200mcg – Accuhaler 1x60D 754P
  • Seretide 50/250mcg – Accuhaler 1x60D 5K8W

 

‘Seek medical advice’

The MHRA recommends patients who have used the affected batches of Ventolin to ‘seek medical advice and returned the inhalers to their pharmacist for a replacement’.

The medicines watchdog’s regulatory assessment unit manager of the inspections, enforcement and standards unit, Bernadette Sinclair Jenkins, said that ‘it is important people check whether they have an affected inhaler’.

She continued: ‘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.

‘We strongly encourage anyone to report any issues with their inhalers or other medicines or medical devices to MHRA via our Yellow Card Scheme.’

No other GSK inhalers have been affected by the issue.


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