Nearly 600,000 inhalers are being recalled.
GlaxoSmithKline is recalling Ventolin (albuterol) inhalers. The recall is voluntary, and only affects the United States, according to an FDA Enforcement Report.
The recall involves three lots of the Ventolin HFA 200D inhalers (6ZP0003, 6ZP9944 and 6ZP9848) manufactured by GSK in Zebulon, NC, totalling about 593,000 units.
The company had received complaints about bulging of the outside wrapper, which indicated a leak in the inhaler’s propellant. This defect may cause the inhaler to deliver fewer doses than indicated on the inhaler's dose counter. The recall affects asthma inhalers from hospital, pharmacies, retailers, and wholesalers, but patients are not affected.
According to GSK spokesman Juan Carlos Molina, GSK does not anticipate a supply impact to Ventolin Inhalers.