FDAFDA · Food and drugs·Recall number D-1452-2016
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.
Published August 10, 2016 · Recall initiated: July 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Let's Talk Health, Inc.
- Distributor
- Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
- Lot
- Lot #15522
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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