Why it was recalled
Marketed Without An Approved NDA/ANDA; Unapproved new 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 53220 1
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
United States including Puerto Rico and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0008-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 9, 2022
- FDA report date
- Oct 19, 2022
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Justified Laboratories
Original FDA data
Every field from FDA enforcement report D-0008-2023, exactly as published.
Show all FDA fields
- City
- Arlington
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 90828
- Address
- 2131 N Collins St
- Address (line 2)
- Ste 433-732
- Code information
- All lots remaining within expiry.
- Postal code
- 76011-2849
- Report date
- Oct 19, 2022
- Product type
- Drugs
- Recall number
- D-0008-2023
- Classification
- Class II
- Recalling firm
- Justified Laboratories
- Product quantity
- Unknown
- Termination date
- Aug 10, 2023
- Reason for recall
- Marketed Without An Approved NDA/ANDA; Unapproved new drug
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- United States including Puerto Rico and Canada
- Recall initiation date
- Sep 9, 2022
- Initial firm notification
- Letter
- Center classification date
- Oct 7, 2022