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FDA (Drug enforcement)Recalled 2013-04-30closedclass i

American Lifestyle.Com: 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 identific

Is my product affected?

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.

  • UPC 893490820087

Check against the official notice below — it lists the full affected range.

What happened

Vicerex, a male sexual enhancer dietary supplement sold in 10-capsule boxes with UPC 893490820087, has been recalled because FDA laboratory analysis found it contains undeclared tadalafil, an FDA-approved prescription drug used to treat male erectile dysfunction. The product was marketed as a dietary supplement without required FDA approval as a new drug, making it an unapproved medication. All lots of this product are affected by the recall.

The product was distributed domestically in 13 boxes and internationally in 50 boxes to countries including Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, and Oman. The source document does not specify what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: 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. Quantity: 13 boxes distributed domestically & 50 boxes distributed internationally to consumers Lot/code info: All lots, UPC 893490820087

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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