PlainRecalls
FDA Drug Low Class III Terminated

Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.

Reported: December 5, 2012 Initiated: October 24, 2012 #D-065-2013

Product Description

Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.

Reason for Recall

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Details

Recalling Firm
GlaxoSmithKline, LLC.
Units Affected
18,676 Aerosol Units
Distribution
Nationwide and Puerto Rico.
Location
Zebulon, NC

Frequently Asked Questions

What product was recalled?
Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.. Recalled by GlaxoSmithKline, LLC.. Units affected: 18,676 Aerosol Units.
Why was this product recalled?
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 5, 2012. Severity: Low. Recall number: D-065-2013.