Exact FDA event identifier

Event 77329

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 16, 2017
Product types: Drug
Classifications: Class II
Statuses: Ongoing
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.

D-0793-2017

Recall number: D-0793-2017
Initiated: May 16, 2017
Classification: Class II
Status: Ongoing
Recalling firm: GlaxoSmithKline, LLC
Quantity: 562,883

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Elevated number of units with out of specification results for leak rate

Code information

Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18

Distribution pattern

Nationwide in the US and Puerto Rico