FDA recall D-1666-2012

GlaxoSmithKline Inc · Class II · drug

Product

Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20

Reason for recall

Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2012-07-26
Report date
2012-09-05
Termination date
2014-09-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Zebulon, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1666-2012