“There is possible risk that the affected inhalers could potentially not deliver the stated number of actuations.”
The recall, approved by U.S. FDA, is due to a defect that may cause them to deliver fewer doses of the medicine than indicated.
“There is possible risk that the affected inhalers could potentially not deliver the stated number of actuations,” spokesman Juan Carlos Molina wrote in an email. “We continue to investigate the issue in order to identify the root cause and implement appropriate corrective and preventative actions.”
According to the British drugmaker, they have received a number of product complaints about the inhalers. According to reports many of the product had a bulging of the outside wrapper, indicating a leak of the propellant that delivers the medicine prompting the recall.
This is not a patient-level recall, so they are not being asked to return inhalers they have already purchased. However, patients whose inhalers are among the affected lots can contact GSK’s customer service center at 1-888-825-5249 with questions. If the devices are not relieving symptoms, patients should seek medical treatment right away.
GSK said it was trying to identify the root cause of the problem and would take corrective action.
“We currently don’t anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue,” GSK said in a statement.
Three lots of Ventolin HFA 200D inhalers have been voluntarily recalled due to a potential issue with the delivery system, a spokesman for the British pharmaceutical company said.
The affected lot numbers are 6ZP0003, 6ZP9944 and 6ZP9848. The devices have been recalled from hospitals, pharmacies, retailers and wholesalers in the United States.