FDA-Drug2017-04-12Class II

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.

GlaxoSmithKline, LLC
Hazard

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

Sold states
Nationwide in the USA and Puerto Rico
Affected count
593,088 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, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0626-2017

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