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.

Source: CBS Boston

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2 Comments

  1. Dennis NeSmith April 9, 2017 at 8:43 am

    I use the Ventolin HFA inhaler as a rescue inhaler usually 3 to 4 puffs four times daily as needed for wheezing. As of lately they have not been as effective and required more usage. I have the inhaler with the lot number 6ZP9944. I still have the box in which it came.

  2. Amanda Couchot April 13, 2017 at 2:03 pm

    I’ve been using these Ventolin HFA for the last two years my breathing is non-stop bad wheezing and stuff I think it’s 10 times worse what do I do I’m on a machine every night for almost an hour

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