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.

Recall Number: D-064-2013

Firm: GlaxoSmithKline, LLC.

Classification: Class III

Status: Terminated

Report Date: 20121205

Initiation Date: 20121024

Termination Date: 20140911

Reason for Recall

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

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.