PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: May 31, 2017 Initiated: May 16, 2017 #D-0793-2017

Product Description

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.

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
562,883
Distribution
Nationwide in the US and Puerto Rico
Location
Zebulon, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by GlaxoSmithKline, LLC. Units affected: 562,883.
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 May 31, 2017. Severity: Moderate. Recall number: D-0793-2017.