GSK Plc is voluntarily recalling more than 593,000 Ventolin asthma inhalers from U.S. hospitals, pharmacies, retailers and wholesalers due to a defect that may cause them to deliver fewer doses of the medicine than indicated, the British drugmaker said on Tuesday.
The company said it had received an elevated number of product complaints about a bulging of the outside wrapper, indicating a leak of the propellant that delivers the medicine.
The recall involves three lots of the Ventolin HFA 200D inhalers manufactured at GSK's plant in Zebulon, North Carolina.
The U.S. Food and Drug Administration has approved the voluntary "Level 2" recall, which only affects products in the United States, GSK spokesman Juan Carlos Molina said.
The defect does not pose a danger to patients, so they are not being asked to return inhalers they have already purchased.
GSK said it was trying to identify the root cause of the problem and would take corrective action.
Meanwhile, the Zebulon plant is still making the inhalers, Molina said.
"We currently don't anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue," GSK said in a statement.