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D-1223-2014 Class I Terminated

Recalled by American Lifestyle.Com — Pittsford, NY

FDA drug recall D-1223-2014 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: 13 boxes distributed domestically & 50 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: 13 boxes distributed domestically & 50 boxes distributed internationally to consumers

Product Description

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.

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 893490820087