Reported Dec 5, 2012 · Terminated
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For…
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 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 codes and dates
Lot #: 1ZP2465Exp Oct-121ZP5224Exp. Nov-121ZP54551ZP6916Exp. Dec-121ZP80421ZP9593Exp Jan-131ZP9900Exp. Mar-131ZP1134Exp. Apr-131ZP31902ZP6531Exp. May-132ZP69242ZP7258Exp. Jul-132ZP18862ZP99752ZP00272ZP9782Exp. Sep-132ZP1331Exp. Oct-132ZP2366Exp. Nov-13
- Amount recalled
- 310,964 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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