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.
Reported: August 10, 2016 Initiated: July 5, 2016 #D-1452-2016
Product 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.
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.
Details
- Recalling Firm
- Let's Talk Health, Inc.
- Units Affected
- 417 bottles
- Distribution
- Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
- Location
- Chula Vista, CA
Frequently Asked Questions
What product 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.. Recalled by Let's Talk Health, Inc.. Units affected: 417 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 10, 2016. Severity: Moderate. Recall number: D-1452-2016.
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