FDA recall D-376-2014

Fabscout Entertainment, Inc · Class I · drug

Product

Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa

Reason for recall

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

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-376-2014