FDA 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.

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-064-2013