FDA recall D-1321-2019

Product

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

Nationwide

Key facts

Status

Terminated

Initiation date

2019-05-06

Report date

2019-06-05

Termination date

2025-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Englewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1321-2019