By Geoff Herbert
Syracuse Media Group
ZEBULON, N.C. — British pharmaceutical company GlaxoSmithKline is recalling more than a half a million asthma inhalers due to a defect.
Reuters reports GSK has issued a voluntary Level II recall of Ventolin inhalers from U.S. hospitals, pharmacies, retailers and wholesalers. More than 593,000 inhalers may have a defect that causes them to administer fewer doses of medicine than indicated, according to the company.
According to CBS, only three lots of Ventolin HFA 200D inhalers (6ZP0003, 6ZP9944 and 6ZP9848) in the United States are affected. The recalled inhalers were manufactured at a GSK plant in Zebulon, North Carolina.
Some customers said a bulge in the inhaler wrapper may indicate a leak of the propellant that administers the medicine.
The company says the defect does not pose a danger to patients. As a result, customers are not being asked to return the 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.”
GSK says it’s trying to identify the cause of the problem and promised to take corrective action. In the meantime, the company is still producing inhalers in N.C.
“We currently don’t anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue,” GSK added in a statement.
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