FDA Recall D-1224-2014

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

Lot / code: All lots, UPC 4026666142546.

Quantity: 3 boxes distributed domestically & 4 boxes distributed internationally to consumers.

Reason for recall

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.

Recall record

Recall number

D-1224-2014

Classification

Class I

Status

Terminated

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution

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.

Recall initiated

2013-04-30

Classified by FDA Center

2014-04-07

FDA published

2014-04-16

Terminated

2018-06-27

Recalling firm

American Lifestyle.Com

Firm location

Pittsford, NY