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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63707

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 24, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
GlaxoSmithKline, LLC.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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.

D-064-2013
Recall number
D-064-2013
Initiated
October 24, 2012
Classification
Class III
Status
Terminated
Recalling firm
GlaxoSmithKline, LLC.
Quantity
310,964 Aerosol Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

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.

Distribution pattern

Nationwide and Puerto Rico.

drug · product 2 of 2

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.

D-065-2013
Recall number
D-065-2013
Initiated
October 24, 2012
Classification
Class III
Status
Terminated
Recalling firm
GlaxoSmithKline, LLC.
Quantity
18,676 Aerosol Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13.

Distribution pattern

Nationwide and Puerto Rico.