Multi-event September 2022 FDA Recall Drug by Justified Laboratories

This Multi-event Class II drug recall was voluntarily initiated by Justified Laboratories on September 9, 2022 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; unapproved new drug. The product was distributed in United States including Puerto Rico and Canada and the recall is currently terminated.

Reported Recall Events

D-0009-2023 TERMINATED D-0008-2023 TERMINATED

Recall Number: D-0009-2023

Reason for Recall
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Initiated
09-09-2022
Reported
10-19-2022
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90828
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.
Justified Laboratories
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-10-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.

Recall Number: D-0008-2023

Reason for Recall
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Initiated
09-09-2022
Reported
10-19-2022
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90828
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.
Justified Laboratories
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-10-2023
Product Description About Product Description
Full technical description of the product.
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.