FDA-Drug2017-05-31Class II

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.

GlaxoSmithKline, LLC
Hazard

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

Sold states
Nationwide in the US and Puerto Rico
Affected count
562,883
Manufactured in
1011 N Arendell Ave, Zebulon, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0793-2017

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