PlainRecalls
FDA Drug Low Class III Terminated

Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.

Reported: December 5, 2012 Initiated: October 24, 2012 #D-064-2013

Product Description

Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.

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
310,964 Aerosol Units
Distribution
Nationwide and Puerto Rico.
Location
Zebulon, NC

Frequently Asked Questions

What product was recalled?
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.. Recalled by GlaxoSmithKline, LLC.. Units affected: 310,964 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-064-2013.