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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class III Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. 310,964 Aerosol Units D-064-2013
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. 1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13. Class III Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. 18,676 Aerosol Units D-065-2013
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