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

American Lifestyle.Com: 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 th

Is my product affected?

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 num

  • UPC 4026666142546

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

What happened

American Lifestyle.Com's Black Ant product (4600 mg x 4, packaged in a small green box with gold lettering) has been recalled because it contains undeclared sildenafil, an FDA-approved drug used to treat male erectile dysfunction. The product is marketed as an unapproved drug, meaning it was sold without required FDA approval. Laboratory analysis by the FDA identified the sildenafil in the product. The affected product has UPC 4026666142546 across all lots.

Three boxes were distributed domestically in the United States, with four additional boxes distributed internationally to consumers in Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, and Oman. The source document does not specify what action affected consumers should take 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: 3 boxes distributed domestically & 4 boxes distributed internationally to consumers. Lot/code info: All lots, UPC 4026666142546.

Source

Official record: FDA (Drug enforcement) ↗

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

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