D-064-2013 Class III Terminated
FDA drug recall D-064-2013 was initiated by GlaxoSmithKline, LLC. on October 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 September 11, 2014). Affected quantity: 310,964 Aerosol Units.
Recall Details
- Product Type
- Drugs
- Report Date
- December 5, 2012
- Initiation Date
- October 24, 2012
- Termination Date
- September 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.