PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 16, 2015 Initiated: December 3, 2015 #D-0519-2016

Product Description

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.

Details

Recalling Firm
GlaxoSmithKline, LLC
Units Affected
128,704 Inhalers
Distribution
MS and VT
Location
Zebulon, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by GlaxoSmithKline, LLC. Units affected: 128,704 Inhalers.
Why was this product recalled?
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 16, 2015. Severity: Moderate. Recall number: D-0519-2016.