Key Takeaway

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, by GlaxoSmithKline, LLC. was recalled on December 3, 2015. The hazard: Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shel...

FDA Drug Class II Terminated

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,

Recalled: December 3, 2015 ~128,704 Inhalers units affected D-0519-2016

Description

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

Hazard / Reason

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: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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,

Drugs

Company Information

GlaxoSmithKline, LLC.

Zebulon, NC, United States

View all 20 recalls by GlaxoSmithKline, LLC. →

Distribution

MS and VT

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