FDA recall D-038-2013

Product

X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida

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-038-2013