FDA Recalls Ventolin HFA for Asthma

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Manufacturer GlaxoSmithKline has issued a voluntary recall for Ventolin HFA, a rescue inhaler used for bronchospasm (asthma).

This is a class II recall, the most common type of recall, which means that there is a situation where the use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.

Who can recall a drug?

A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled Ventolin HFA, with the knowledge of the FDA.

Why was Ventolin HFA recalled?

Defective Ventolin HFA inhalers have been found to have a possible leakage in the canister. This can cause the inhaler to administer fewer doses of medication than it should.

At this time there have not been any adverse events reported and the defect doesn’t pose a serious health risk to the patient. However, since the canister is releasing fewer doses, this may cause patients to run out of medication and need a refill sooner than expected.

Which products were recalled?

The 3 affected lots were shipped between January 4th, 2017 and February 6th, 2017 to retail pharmacies and wholesale distributors throughout the United States. This recall will affect the following:

Are there any other products similar to Ventolin HFA?

Yes. Ventolin HFA is a rescue inhaler that contains albuterol. Several other companies make similar inhalers like ProAir HFA, ProAir Respiclick, Proventil HFA.

What should I do if I have an affected lot?

If you think you have the recalled Ventolin HFA product, contact your pharmacy immediately. You can also contact GlaxoSmithKline, the manufacturer of Ventolin HFA, by calling 1-888-825-5249.

If you ever notice that your medication looks different than your previous fill, ask your pharmacist. In rare instances, such as this drug recall, manufacturers and their processes fail. Contacting the manufacturer and/or letting your pharmacist know is important so that these types of incidents can be properly reported.

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