Key Takeaway

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. by Let's Talk Health, Inc. was recalled on July 5, 2016. 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 deconges...

FDA Drug Class II Terminated

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.

Recalled: July 5, 2016 ~417 bottles units affected D-1452-2016

Description

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.

Hazard / Reason

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: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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.

Drugs

Company Information

Let's Talk Health, Inc.

Chula Vista, CA, United States

View all 7 recalls by Let's Talk Health, Inc. →

Distribution

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

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Frequently Asked Questions

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