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, called albuterol.

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, said GSK spokesman Juan Carlos Molina said.

Level 2 recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature, the FDA's website says.

The recall does not apply in Canada, GSK spokeswoman Michelle Smolen said. "Ventolin continues to be available in Canada."



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.