Drug 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.
D-065-2013
Product summary
- Event
- Event 63707
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18,676 Aerosol Units
- Official record key
drug-enforcement:D-065-2013
Official wording
Reason: Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Code information: 1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Unknown
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.