Let's Talk Health Recalls Unapproved Oxygen Nasal Wash Solution
Let's Talk Health is recalling 417 bottles of Oxygen Nasal Wash because the product was marketed without FDA approval and does not comply with nasal decongestant monograph requirements.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which per the rubric corresponds to a 'Severe' severity score (4) due to the potential for temporary or medically reversible adverse health consequences from using an unapproved drug.
Plain-English summary
Let's Talk Health, Inc. is recalling 417 bottles of Oxygen Nasal Wash solution, .75 oz (22mL) size. The product contains purified water, xylitol, stabilized oxygen, and sodium chloride. The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product does not comply with the nasal decongestant final monograph.
The affected product is identified by Lot #15522. The recall covers distribution in the United States, Australia, Austria, Canada, Lebanon, Malaysia, and the Philippines. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased this product should stop using it and contact Let's Talk Health, Inc. for further instructions or a refund. The recall is voluntary and is being conducted to ensure compliance with FDA regulations regarding unapproved drugs and monograph compliance.
The recalled product
- Product
- 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.
- Manufacturer
- Let's Talk Health, Inc.
- Category
- Drug — Nasal Decongestant
- Affected units
- 417
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #15522
Distribution
Distributed nationwide across the United States.
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