Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Met...
FDA Recall #D-064-2013 — Class III — October 24, 2012
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.
Recalling Firm
GlaxoSmithKline, LLC. — Zebulon, NC
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
310,964 Aerosol Units
Distribution
Nationwide and Puerto Rico.
Code Information
Lot #: 1ZP2465, Exp Oct-12, 1ZP5224, Exp. Nov-12, 1ZP5455, 1ZP6916, Exp. Dec-12, 1ZP8042, 1ZP9593, Exp Jan-13, 1ZP9900, Exp. Mar-13, 1ZP1134, Exp. Apr-13, 1ZP3190, 2ZP6531, Exp. May-13, 2ZP6924, 2ZP7258, Exp. Jul-13, 2ZP1886, 2ZP9975, 2ZP0027, 2ZP9782, Exp. Sep-13, 2ZP1331, Exp. Oct-13, 2ZP2366, Exp. Nov-13.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated