FDA recall D-0626-2017

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Ongoing

Initiation date

2017-03-22

Report date

2017-04-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Zebulon, NC, United States

Primary source

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