Why it was recalled
Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Product description
The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide
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-1321-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 6, 2019
- FDA report date
- Jun 5, 2019
- Quantity
- 1000 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Stiff Boy LLC
Original FDA data
Every field from FDA enforcement report D-1321-2019, exactly as published.
Show all FDA fields
- City
- Englewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82704
- Address
- 90 Highwood Ave
- Code information
- All lots
- Postal code
- 07631-1717
- Report date
- Jun 5, 2019
- Product type
- Drugs
- Recall number
- D-1321-2019
- Classification
- Class I
- Recalling firm
- Stiff Boy LLC
- Product quantity
- 1000 boxes
- Termination date
- Sep 16, 2025
- Reason for recall
- Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 6, 2019
- Initial firm notification
- Press Release
- Center classification date
- Jun 5, 2019