FDA-Drug2015-12-16Class II

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

GlaxoSmithKline, LLC
Hazard

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

Sold states
MS and VT
Affected count
128,704 Inhalers
Manufactured in
1011 N Arendell Ave, N/A, Zebulon, NC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2016

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