GlaxoSmithKline (GSK) has issued a voluntary Class II recall of 562,883 Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200-metered inhalations, net weight, 18-g inhalers due to a defective delivery systems.

The recall was due to an elevated number of units with out-of-specification results for a leak rate. 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 was initiated on May 16, 2017 by GlaxoSmithKline LLC, a GSK company in Zebulon, North Carolina in the US, including Puerto Rico. 

In March 2017, GSK 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 similar issue. 

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: US Food and Drug Administration