FDA Recalls Enforcement Reports
The last Recall Enforcement Report for Advair Hfa with NDC 0173-0715 was initiated on 10-24-2012 as a Class III recall due to product lacks stability: these lots are being recalled due to the failure to meet the particle size distribution specification. The latest recall number for this product is D-065-2013 and the recall is currently terminated as of 09-11-2014 .
|Recall Number||Initiation Date||Report Date||Recall Classification||Product Quantity||Product Description||Status|
|D-065-2013||10-24-2012||12-05-2012||Class III||18,676 Aerosol Units||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.||Terminated|
|D-064-2013||10-24-2012||12-05-2012||Class III||310,964 Aerosol Units||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.||Terminated|
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.