D-065-2013 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 5, 2012
- Initiation Date
- October 24, 2012
- Termination Date
- September 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,676 Aerosol Units
Product Description
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.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.