Drug recall D-064-2013
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.
Reason for recall
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Lots and codes
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.
Recall details
- Recalling firm
- GlaxoSmithKline, LLC., Zebulon, NC
- Quantity
- 310,964 Aerosol Units
- Distribution
- Nationwide and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 24, 2012
- Terminated
- September 11, 2014
Related products
- Advair Hfa – drug information
- NDC 0173-0715 Advair Hfa · Fluticasone Propionate 45 ug/1; Salmeterol Xinafoate 21 ug/1 · GlaxoSmithKline LLC
- NDC 0173-0717 Advair Hfa · Fluticasone Propionate 230 ug/1; Salmeterol Xinafoate 21… · GlaxoSmithKline LLC
- NDC 0173-0716 Advair Hfa · Fluticasone Propionate 115 ug/1; Salmeterol Xinafoate 21… · GlaxoSmithKline LLC