Reported Dec 5, 2012 · Terminated
Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22,…
GlaxoSmithKline, LLC.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GlaxoSmithKline, LLC. · 1011 North Arendell Ave · Zebulon, NC · 27597-1217
Is this the product you have?
- 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.
- Lot codes and dates
1ZP3065Exp. Oct-121ZP5453Exp. Dec-121ZP3315Exp. May-132ZP9974Exp. Sep-13
- Amount recalled
- 18,676 Aerosol Units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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