FDA recall D-065-2013

Product

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

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2012-10-24

Report date

2012-12-05

Termination date

2014-09-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Zebulon, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-065-2013