D-065-2013 Class III Terminated
FDA drug recall D-065-2013 was initiated by GlaxoSmithKline, LLC. on Oct 24, 2012 and is designated Class III. Reason for recall: Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. The recall status is terminated (terminated Sep 11, 2014). Affected quantity: 18,676 Aerosol Units.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 5, 2012
- Initiation Date
- Oct 24, 2012
- Termination Date
- Sep 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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-065-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026