Advair Hfa Aerosol, Metered
FDA Recall NDC 0173-0717
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Advair Hfa (NDC 0173-0717). A significant event, classified as Class III, was initiated on Oct 24, 2012 by Glaxosmithkline Llc. The reported reason for this action was: "Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Oct 24, 2012
Dec 05, 2012
18,676 Aerosol Units
Recall Profile & Regulatory Data
Event ID
63707
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline, LLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Sep 11, 2014
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.
Batch or Lot Expiration Information
Lot# 1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
Affected Packages Involved in this Recall
0173-0715-20Product
0173-0715-22Product
0173-0716-20Product
0173-0716-22Product
0173-0717-20Product
0173-0717-22Product
Class III Terminated
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Oct 24, 2012
Dec 05, 2012
310,964 Aerosol Units
Recall Profile & Regulatory Data
Event ID
63707
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline, LLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Sep 11, 2014
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.
Batch or Lot Expiration 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.
Affected Packages Involved in this Recall
0173-0715-20Product
0173-0715-22Product
0173-0716-20Product
0173-0716-22Product
0173-0717-20Product
0173-0717-22Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
