FDA recall D-1452-2016

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.

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

Key facts

Status

Terminated

Initiation date

2016-07-05

Report date

2016-08-10

Termination date

2017-06-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chula Vista, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1452-2016