GlaxoSmithKline, LLC recalls Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx o…

Recall date

May 16, 2017

Source

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

Recall number

D-0793-2017

FDA classification

Class II

Brand / firm

GlaxoSmithKline, LLC

Sold / distributed

Nationwide in the US and Puerto Rico

Why it was recalled

Defective Delivery System: Elevated number of units with out of specification results for leak rate

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, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.