FDA recall D-0009-2023

Justified Laboratories · Class II · drug

Product

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

United States including Puerto Rico and Canada

Key facts

Status
Terminated
Initiation date
2022-09-09
Report date
2022-10-19
Termination date
2023-08-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Arlington, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2023