Home / Recalls / Justified Laboratories / D-0009-2023

D-0009-2023 Class II Terminated

Recalled by Justified Laboratories — Arlington, TX

FDA drug recall D-0009-2023 was initiated by Justified Laboratories on September 9, 2022 and is designated Class II. Reason for recall: Marketed Without An Approved NDA/ANDA; Unapproved new drug The recall status is terminated (terminated August 10, 2023). Affected quantity: Unknown.

Recall Details

Product Type: Drugs
Report Date: October 19, 2022
Initiation Date: September 9, 2022
Termination Date: August 10, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Unknown

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

Reason for Recall

Marketed Without An Approved NDA/ANDA; Unapproved new drug

Distribution Pattern

United States including Puerto Rico and Canada

Code Information

All lots remaining within expiry.