Let's Talk Health, Inc. recalls Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distribu
Recalled August 10, 2016 · FDA recall D-1452-2016 · Let's Talk Health
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. · FDA Class II
Units
417 bottles
Sold at
Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
Description
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.
Product
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.
Manufacturer(s)
Let's Talk Health, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →