July 2019 FDA Recall Drug by La Fresh Group, Inc.
D-1566-2019 - Marketed without an Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by La Fresh Group, Inc. on July 15, 2019 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Firm's website sales and www.Amazon.com and the recall is currently terminated.

Recall Number: D-1566-2019

Reason for Recall
Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
Initiated
07-15-2019
Reported
07-31-2019
Quantity
83,050 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82857
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.
La Fresh Group, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Firm's website sales and www.Amazon.com
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-09-2021
Product Description About Product Description
Full technical description of the product.
LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octinoxate, Ethylhexylglycerine, Phenoxyethanol, Distributed by La Fresh Group, Inc. Chino, CA 91710 www.LaFreshGroup.com

Batch or Lot Expiration Information

Lot# All lots beginning with 453091