Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) pe
Summary
The FDA issued a Class III for Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pou by Eco Lips, Inc. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
D-1298-2022
Action Date
2022-08-03
Status
Terminated
Category
drug
Product Description
Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
Lot/Code Info: Lot#: 90121-20321 Exp: 11/2023
Quantity Affected: 15,313 tubes
Reason for Recall
Failed Dissolution Specifications
Distribution
CA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-29
Company
Cedar Rapids, IA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 77 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Eco Lips, Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Eco Lips, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eco Lips, Inc have FDA actions?
Eco Lips, Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1298-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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