D-1452-2016 Class II Terminated
FDA drug recall D-1452-2016 was initiated by Let's Talk Health, Inc. on July 5, 2016 and is designated Class II. 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. The recall status is terminated (terminated June 6, 2017). Affected quantity: 417 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 10, 2016
- Initiation Date
- July 5, 2016
- Termination Date
- June 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 417 bottles
Product Description
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 Pattern
Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
Code Information
Lot #15522