PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: April 12, 2017 Initiated: March 22, 2017 #D-0626-2017

Product Description

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.

Details

Recalling Firm
GlaxoSmithKline, LLC
Units Affected
593,088 inhalers
Distribution
Nationwide in the USA and Puerto Rico
Location
Zebulon, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by GlaxoSmithKline, LLC. Units affected: 593,088 inhalers.
Why was this product recalled?
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 12, 2017. Severity: Moderate. Recall number: D-0626-2017.