GlaxoSmithKline (GSK) has voluntarily recalled 593,088 Ventolin HFA (albuterol sulfate) inhalers due to an issue with the delivery system.
According to the US Food and Drug Administration (FDA), there were an elevated number of units with out of specification results for leak rate.
The affected lot numbers and expiration dates are Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
The affected units are being recalled from hospitals, pharmacies, retailers and wholesalers in the United States. It’s not a patient-level recall, but patients whose inhalers are among the affected lots can contact GSK’s customer service center at 1-888-825-5249 with questions.
Albuterol is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.
Albuterol inhalation is used to treat or prevent bronchospasm in people with reversible obstructive airway disease. It is also used to prevent exercise-induced bronchospasm.
Metered-dose albuterol inhalers are used to deliver medication into the body through the airway and lungs.