FDA recall D-039-2013

Coral Rock Man, Inc. · Class I · drug

Product

Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066

Reason for recall

Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.

Distribution

Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.

Key facts

Status
Terminated
Initiation date
2012-07-16
Report date
2012-11-07
Termination date
2015-11-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Key Colony Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-039-2013