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.
This recall has been terminated (originally issued August 10, 2016).
- Company
- Let'S Talk Health, Inc.
- Recall Initiated
- July 5, 2016
- Posted
- August 10, 2016
- Recall Number
- D-1452-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 417 bottles
- Firm Location
- Chula Vista, CA, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
Lot / Code Info
Lot #15522
More recalls by Let'S Talk Health, Inc.
Let's Talk Health Agua Vitae Kids Multi-Vitamin Liquid 16 oz. UPC #91131180280
Jun 29, 2016 · Class I
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