The Recall Desk

FDA (Drugs) recall action 66897

Tendex recalled 2 products on 2014-05-28

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
2014-05-28
Critical
1
Units
—

Why these products were recalled

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.

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

1–2 of 2

  • SevereFDA (Drugs)··2014-05-28

    P-Boost Capsules Recalled for Undeclared Tadalafil Ingredient

    Tendex is recalling P-Boost Capsules because FDA analysis found the product contains undeclared tadalafil, making it an unapproved drug.

    Product
    P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2014-05-28

    Naturect Capsules Recalled for Undeclared Tadalafil Ingredient

    Tendex is recalling Naturect Capsules because FDA analysis found the product contains undeclared tadalafil, making it an unapproved drug.

    Product
    NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466
    Category
    Distribution
    0 states