The Recall Desk

FDA (Drugs) recall action 72522

Premiere Sales Group recalled 2 products on 2016-02-24

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
2016-02-24
Critical
2
Units
337

Why these products were recalled

Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • CriticalFDA (Drugs)··2016-02-24

    Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients

    FDA recalls Rhino 7 Platinum 3000 because it contains undeclared active pharmaceutical ingredients, desmethyl carbondenafil and dapoxetine.

    Product
    Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2016-02-24

    Rhino 7 3000 Recalled for Undeclared Active Pharmaceutical Ingredients

    Premiere Sales Group is recalling Rhino 7 3000 bottles because they contain undeclared active pharmaceutical ingredients, desmethyl carbondenafil and dapoxetine.

    Product
    Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
    Category
    Distribution
    0 states