GlaxoSmithKline (GSK) has issued a voluntary Class II recall of 593,088 inhalers of Ventolin HFA (albuterol sulfate) inhalation aerosol, 90 microgram per actuation, 200 metered inhalations, net weight 18 grams, in the US and Puerto Rico due to a defective delivery system that resulted in an elevated number of units with out of specification results for leak rate. GlaxoSmithKline LLC, a GSK company in Zebulon, North Carolina, initiated the recall in March 2017, and the US Food and Drug Administration noted the recall on its website on March 31, 2017.

A Class II recall is a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The recall applies to prescription-only Ventolin inhalers. Ventolin is a beta-2-adrenergic agonist indicated for treating or preventing bronchospasm with reversible obstructive airway disease and for preventing exercise-induced bronchospasm. The drug, which had 2016 sales of £785 million ($980 million), is part of GSK’s respiratory franchise, which earned 2016 sales of £6.5 billion ($8.1 billion)

Source: Food and Drug Administration