Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations IN...
FDA Recall #D-065-2013 — Class III — October 24, 2012
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.
Recalling Firm
GlaxoSmithKline, LLC. — Zebulon, NC
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
18,676 Aerosol Units
Distribution
Nationwide and Puerto Rico.
Code Information
1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated