GlaxoSmithKline (GSK) is recalling more than a half million Ventolin asthma inhalers in the U.S. due to a defect that may cause them to deliver less medication than indicated. The recall is being initiated at hospitals, pharmacies, retailers and wholesalers.
The recall is listed by the Food and Drug Administration (FDA) as a Class II recall, which involves situations in which exposure to the violative product may cause temporary or medically reversible adverse health consequences or where there probability of serious adverse health consequences is remote.
GSK ordered the recall after receiving an unusually high number of product complaints about a bulging of the outside wrapper, indicating a leak of the propellant that delivers the medicine. The recall affects three lots – or more than 593,000 – Ventolin HFA 200D inhalers manufactured at the company’s plant in Zebulon, North Carolina.
GSK said it was working to identify the root cause of the problem and would take corrective action. In the interim, the Zebulon plant is continuing to manufacture the inhalers.
Patients who have the inhaler are asked to return them to the place of purchase. Any adverse events or quality issues related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.