Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011
Summary
The FDA issued a Class II for Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Jus by Justified Laboratories. Reason: Marketed Without An Approved NDA/ANDA; Unapproved new drug.
Details
Source
Drug Recall
External ID
D-0009-2023
Action Date
2022-10-19
Status
Terminated
Category
drug
Product Description
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8
Lot/Code Info: All lots remaining within expiry.
Quantity Affected: Unknown
Reason for Recall
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Distribution
United States including Puerto Rico and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-09
Company
Arlington, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 31 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Justified Laboratories has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Justified Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Justified Laboratories have FDA actions?
Justified Laboratories has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0009-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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