FDA recall D-0519-2016

Product

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

Reason for recall

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

Distribution

MS and VT

Key facts

Status

Terminated

Initiation date

2015-12-03

Report date

2015-12-16

Termination date

2016-10-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Zebulon, NC, United States

Primary source

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