Drug recall D-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.
Reason for recall
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Lots and codes
1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
Recall details
- Recalling firm
- GlaxoSmithKline, LLC., Zebulon, NC
- Quantity
- 18,676 Aerosol Units
- Distribution
- Nationwide and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 24, 2012
- Terminated
- September 11, 2014
Related products
- Advair Hfa – drug information
- NDC 0173-0715 Advair Hfa · Fluticasone Propionate 45 ug/1; Salmeterol Xinafoate 21 ug/1 · GlaxoSmithKline LLC
- NDC 0173-0717 Advair Hfa · Fluticasone Propionate 230 ug/1; Salmeterol Xinafoate 21… · GlaxoSmithKline LLC
- NDC 0173-0716 Advair Hfa · Fluticasone Propionate 115 ug/1; Salmeterol Xinafoate 21… · GlaxoSmithKline LLC