A high number of GSK Ventolin HFA inhalers were reported to be leaking at a rate faster than the acceptable specifications, according to an FDA Enforcement Report. The devices are supposed to deliver 200 metered inhalations of albuterol sulfate, but that could be undercut by a leak.
Recalled lot numbers include:
6ZP9848, Exp 03/18
6ZP0003, 6ZP9944, Exp 04/18
The inhalers were manufactured in Zebulon, North Carolina, and distributed throughout the U.S. and Puerto Rico.
GSK is working to identify the cause of the problem. Some customers said a bulge in the inhaler wrapper may indicate a leak of the propellant that administers the ventolin.
“We currently don’t anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue,” GSK said.
This is an FDA Class II recall, which means that use of the device “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Consumers are not being instructed to return the inhalers because the defect poses no danger.