D-064-2013 Class III Terminated
FDA drug recall D-064-2013 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: 310,964 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
- 310,964 Aerosol Units
Product description
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.
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
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-064-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026