D-1224-2014 Class I Terminated
FDA drug recall D-1224-2014 was initiated by American Lifestyle.Com on April 30, 2013 and is designated Class I. 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 sildenafi… The recall status is terminated (terminated June 27, 2018). Affected quantity: 3 boxes distributed domestically & 4 boxes distributed internationally to consumers..
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2014
- Initiation Date
- April 30, 2013
- Termination Date
- June 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 boxes distributed domestically & 4 boxes distributed internationally to consumers.
Product Description
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).
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.
Distribution Pattern
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.
Code Information
All lots, UPC 4026666142546.