Status
Terminated
Drug Enforcement D-065-2013
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Classification
Class III
Report Date
December 5, 2012
Termination Date
September 11, 2014
Product Information
- 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.
- Product quantity
- 18,676 Aerosol Units
- Reason for recall
- Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- GlaxoSmithKline, LLC.
- Address
-
1011 North Arendell Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-065-2013
- Event ID
- 63707
- Recall initiation date
- October 24, 2012
- Center classification date
- November 23, 2012
- Code info
- 1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.
- More code info
- —