July 2016 FDA Recall Drug by Let's Talk Health, Inc.
D-1452-2016 - Marketed Without An Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Let's Talk Health, Inc. on July 5, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1452-2016

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.
Initiated
07-05-2016
Reported
08-10-2016
Quantity
417 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74605
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Let's Talk Health, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-06-2017
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 15522