Why it was recalled
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.
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).
Lot numbers, UPCs & expiration codes
All lots, UPC 4026666142546.
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1224-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 30, 2013
- FDA report date
- Apr 16, 2014
- Quantity
- 3 boxes distributed domestically & 4 boxes distributed internationally to consumers.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Lifestyle.Com
Original FDA data
Every field from FDA enforcement report D-1224-2014, exactly as published.
Show all FDA fields
- City
- Pittsford
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65095
- Address
- 640 Kreag Rd Ste 101
- Code information
- All lots, UPC 4026666142546.
- Postal code
- 14534-3737
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1224-2014
- Classification
- Class I
- Recalling firm
- American Lifestyle.Com
- Product quantity
- 3 boxes distributed domestically & 4 boxes distributed internationally to consumers.
- Termination date
- Jun 27, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- 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.
- Recall initiation date
- Apr 30, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 7, 2014