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FDAFDA · Food and drugs·Recall number D-1224-2014

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 4026666142546 (product numbers may possibly vary for same product identification and same product packaging).

Published April 16, 2014 · Recall initiated: April 30, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
American Lifestyle.Com
Distributor
Domestic distribution currently under Investigation; International distribution includes, but may not be limited to the following countries : Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, Oman.
Lot
All lots, UPC 4026666142546.
Risk classification
Class I
Area (FDA)
drug
Country
United States

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