Recalls / Class III
Class IIID-064-2013
Product
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.
- 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
- Lot #: 1ZP2465, Exp Oct-12, 1ZP5224, Exp. Nov-12, 1ZP5455, 1ZP6916, Exp. Dec-12, 1ZP8042, 1ZP9593, Exp Jan-13, 1ZP9900, Exp. Mar-13, 1ZP1134, Exp. Apr-13, 1ZP3190, 2ZP6531, Exp. May-13, 2ZP6924, 2ZP7258, Exp. Jul-13, 2ZP1886, 2ZP9975, 2ZP0027, 2ZP9782, Exp. Sep-13, 2ZP1331, Exp. Oct-13, 2ZP2366, Exp. Nov-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
- 310,964 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-064-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.