FDA-Drug2012-12-05Class III

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.

GlaxoSmithKline, LLC.
Hazard

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Sold states
Nationwide and Puerto Rico.
Affected count
310,964 Aerosol Units
Manufactured in
1011 North Arendell Ave, N/A, Zebulon, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-064-2013

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