Drug 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.
D-1452-2016
Product summary
- Event
- Event 74605
- Status
- Terminated
- Classification
- Class II
- Quantity
- 417 bottles
- Official record key
drug-enforcement:D-1452-2016
Official wording
Reason: 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.
Code information: Lot #15522
Distribution pattern: Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
Derived failure modes
-
Unknown
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.