Class I · High risk
BEEKEEPER'S NATURALS Saline Nasal Spray
Microbial Contamination of Non-Sterile Products
Oxygen Nasal Wash
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
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.
Drug: Xylitol
- Recalling firm
- Let's Talk Health, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1452-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Xylitol recalls
See all
Class II · Moderate risk
Walgreens Saline Nasal Spray WITH XYLITOL
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Other unapproved drug recalls from 2016
All unapproved drug recalls
Class I · High risk
Domperidone capsules 10 mg
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Class II · Moderate risk
Zinc Acetate
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Class II · Moderate risk
Fuqingsong Relief Cream
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Te Xiao BaiNeiTing Herbal Supplement
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
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