The recall affects three lots of Ventolin HFA 200D inhalers manufactured at GSK’s plant in Zebulon, North Carolina.
According to Reuters, the recall was issued after GSK received an elevated number of product complaints concerning a bulging of the outside wrapper. Normally, this would indicate a leak of the propellant that delivers the medicine
The FDA has identified the recall as a “Level 2” recall. GSK is currently working to determine the cause of the problem.
Less than 18 months ago, GSK recalled 130,000 inhalers due to concerns that canisters might not contain enough propellant to deliver the 200 doses indicated on product labels.
GSK has been trying to increase its inhaler output in recent years, and last year it opened a new plant in the U.K. that would allow the company to double its production of Ellipta inhalers.