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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Detail

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.
Recall Number D-065-2013
Classification Class III
Code Info 1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
Product Distributed Qty 18,676 Aerosol Units
Reason For Recall Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Event Detail

Event Id 63707
Product Type Drugs
Status Ongoing
Recalling Firm GlaxoSmithKline, LLC.
City Zebulon
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico.