GSK withdraws asthma inhalers in US
GlaxoSmithKline is recalling more than 593,000 asthma inhalers in the US due to a defect that may cause them to deliver fewer doses of the medicine than indicated.
The company said it would be withdrawing the Ventolin inhalers from US hospitals, pharmacies, retailers and wholesalers.
GSK said it had received an increase in the number of product complaints about a bulging of the outside wrapper, suggesting a leak of the propellant that delivers the medicine.
The recall involves three lots of the Ventolin inhalers manufactured at GSK’s plant in Zebulon, North Carolina.
The FDA has approved the voluntary “Level 2” recall, which only affects products in the United States, a GSK spokesperson told Reuters.
The defect is not dangerous to patients, GSK said, so they are not being asked to return inhalers they have already bought.
GSK said it was trying to identify the root cause of the problem and will rectify it.
Meanwhile, the Zebulon plant is still making the inhalers, Molina said.
GSK said it did not anticipate the supply of inhalers to be affected.
The situation will be the first test for incoming CEO Emma Walmsley, who took over from the retiring Sir Andrew Witty at the beginning of the month.
GSK’s important respiratory business is already under pressure in the US, because of falling sales of its mainstay product, Advair.
The UK company got a let-off when the FDA rejected a generic competitor from Mylan, but Hikma could still get a cheaper version approved in the US, significantly affecting GSK’s financial performance.
Without a generic competitor GSK has said its sales will grow slightly but if one is approved, growth will be flat, the company said in its full-year results earlier this year.
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