Recalls / Class III
Class IIID-065-2013
Product
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.
- Brand name
- Advair Hfa
- Generic name
- Fluticasone Propionate And Salmeterol Xinafoate
- Active ingredients
- Fluticasone Propionate, Salmeterol Xinafoate
- Route
- Respiratory (inhalation)
- NDCs
- 0173-0715, 0173-0716, 0173-0717
- FDA application
- NDA021254
- Affected lot / code info
- 1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
Why it was recalled
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Recalling firm
- Firm
- GlaxoSmithKline, LLC.
- Manufacturer
- GlaxoSmithKline LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 North Arendell Ave, N/A, Zebulon, North Carolina 27597-1217
Distribution
- Quantity
- 18,676 Aerosol Units
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2012-10-24
- FDA classified
- 2012-11-23
- Posted by FDA
- 2012-12-05
- Terminated
- 2014-09-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-065-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.