The Recall Desk

FDA (Drugs) recall action 65095

American Lifestyle.Com recalled 2 products on 2014-04-16

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
2014-04-16
Critical
1
Units
—

Why these products were recalled

Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.

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

1–2 of 2

  • CriticalFDA (Drugs)··2014-04-16

    FDA Recalls Vicerex Male Sexual Enhancer for Undeclared Tadalafil

    The FDA is recalling Vicerex male sexual enhancer capsules because laboratory analysis found undeclared tadalafil, an unapproved drug ingredient.

    Product
    Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2014-04-16

    FDA Recalls Black Ant Supplement Containing Undeclared Sildenafil

    The FDA is recalling Black Ant dietary supplements because laboratory analysis found they contain undeclared sildenafil, an FDA-approved drug for erectile dysfunction.

    Product
    Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 402
    Category
    Distribution
    0 states