GlaxoSmithKline has recalled two lots of Ventolin HFA metered dose inhalers totaling 128,704 inhalers, according to an FDA enforcement report. The company initiated the voluntary recall on December 3, 2015 due to concerns about insufficient propellant in the cans for delivery of all 200 doses. According to a copy of the recall letter posted by a distributor, the company is recalling the inhalers only at the wholesale and retail levels.
The MDIs were manufactured at the company’s Zebulon, NC facility, which manufactures and packages over 65 million MDIs and DPIs per year, including Advair and Breo Ellipta.
A spokesperson for GSK said that the issue is a leakage problem and that Ventolin production has been halted at Zebulon while a root cause investigation is underway. GSK will supply US customers with Ventolin manufactured at a facility in France for now.
View the FDA enforcement report.
