Reported Aug 10, 2016 · Terminated
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle,…
Let's Talk Health, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Let's Talk Health, Inc. · 2411 Fenton St Ste 102 · Chula Vista, CA · 91914-3517
Is this the product you have?
- Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle
- Distributed byLet's Talk Health, Chula Vista, CA 91914
- Lot codes and dates
- Lot #15522
- Amount recalled
- 417 bottles
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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