FDA recall D-378-2014

Fabscout Entertainment, Inc · Class I · drug

Product

PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC

Reason for recall

Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil

Distribution

CA, FL and UT

Key facts

Status
Terminated
Initiation date
2013-08-14
Report date
2013-12-25
Termination date
2021-02-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ft Lauderdale, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-378-2014