Status
Terminated
Drug Enforcement D-0008-2023
Marketed Without An Approved NDA/ANDA; Unapproved new drug
1 Views
Classification
Class II
Report Date
October 19, 2022
Termination Date
August 10, 2023
Product Information
- Product description
- Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1
- Product quantity
- Unknown
- Reason for recall
- Marketed Without An Approved NDA/ANDA; Unapproved new drug
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States including Puerto Rico and Canada
Location & Firm
- Recalling firm
- Justified Laboratories
- Address
-
2131 N Collins St, Ste 433-732
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0008-2023
- Event ID
- 90828
- Recall initiation date
- September 9, 2022
- Center classification date
- October 7, 2022
- Code info
- All lots remaining within expiry.
- More code info
- —