British pharmaceutical company GlaxoSmithKline has announced a recall of more than 593,000 asthma inhalers in the United States because of a defect that may affect the doses delivered.
Reuters reported that the inhalers are being recalled from hospitals, pharmacies, retailers and wholesalers.
The U.S. Food and Drug Administration approved a voluntary level II recall of some
Ventolin asthma inhalers. The FDA says a level II recall means use of the device “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The recalled items include three lots of the Ventolin HFA 200D inhalers. They are manufactured at GSK’s Zebulon, North Carolina, plant. Customers complained about a bulge in the inhaler wrapper that may indicate a leak of the propellant that administers the medicine.
“We currently don't anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue,” GSK said in a statement.
The company said the defect does not pose a danger to patients.
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