RecallRadar

FDA Drug recall D-065-2013

Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKl…

On 2012-12-05 the FDA classified a Class III recall of Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKl… by Glaxosmithkline, citing product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-065-2013
ClassificationClass III
Statusterminated
Initiated2012-10-24
Published2012-12-05
Last updated2026-09-13 11:51 UTC
CompanyGlaxosmithkline
DistributionUS

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

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Identifiers

ndc0173-0715-20
ndc0173-0715-22
ndc0173-0716-20
ndc0173-0716-22
ndc0173-0717-20
ndc0173-0717-22
code_info1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-065-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.