FDA recall D-037-2013

Product

X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.

Reason for recall

Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).

Distribution

Products were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom.

Key facts

Status

Terminated

Initiation date

2012-04-21

Report date

2012-11-07

Termination date

2015-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pompano Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-037-2013