Drug 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.
D-064-2013
Product summary
- Event
- Event 63707
- Status
- Terminated
- Classification
- Class III
- Quantity
- 310,964 Aerosol Units
- Official record key
drug-enforcement:D-064-2013
Official wording
Reason: Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Code information: 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.
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.