Let's Talk Health, Inc. recalls Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distrib…
- Recall date
- July 5, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1452-2016
- FDA classification
- Class II
- Brand / firm
- Let's Talk Health, Inc.
- Sold / distributed
- Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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