The Recall Desk

FDA (Drugs) recall action 90828

Justified Laboratories recalled 2 products on 2022-10-19

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-10-19
Critical
0
Units
—

Why these products were recalled

Marketed Without An Approved NDA/ANDA; Unapproved new drug

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Drugs)··2022-10-19

    Skincell Mole & Skin Corrector Serum Recalled Due to Unapproved Drug Status

    Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum because it was marketed without FDA approval. The affected product was distributed throughout the United States, Puerto Rico, and Canada.

    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
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2022-10-19

    Skincell Mole & Skin Corrector Serum recalled as unapproved drug

    Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum. The product was marketed as a drug without FDA approval (NDA/ANDA).

    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
    Category
    Distribution
    1 state