GlaxoSmithKline, LLC recalls Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral…

Recall date

December 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0519-2016

FDA classification

Class II

Brand / firm

GlaxoSmithKline, LLC

Sold / distributed

MS and VT

Why it was recalled

Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20