D-1321-2019 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 5, 2019
- Initiation Date
- May 6, 2019
- Termination Date
- September 16, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1000 boxes
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.
Reason for Recall
Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Distribution Pattern
Nationwide
Code Information
All lots