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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74605

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

Open FDA event record

Event summary

Timeline bucket
July 05, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Let's Talk Health, Inc.

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

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

Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.

D-1452-2016
Recall number
D-1452-2016
Initiated
July 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Let's Talk Health, Inc.
Quantity
417 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.

Code information

Lot #15522

Distribution pattern

Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines