The Recall Desk

FDA (Drugs) recall action 79967

Ideaz Llc recalled 2 products on 2018-05-30

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
2018-05-30
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.

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

1–2 of 2

  • SevereFDA (Drugs)··2018-05-30

    Ideaz Recalls Screamin' Menthol Pain Gel Due to Benzene Levels

    Ideaz Llc is recalling Screamin' Menthol Pain Relieving Gel because it contains benzene levels exceeding FDA limits.

    Product
    screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC…
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-05-30

    Ideaz Recalls Screamin' Hot Pain Gel Due to Benzene Levels

    Ideaz LLC is recalling Screamin' Hot Pain Relieving Gel because it was manufactured with benzene levels exceeding FDA limits.

    Product
    screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC…
    Category
    Distribution
    0 states