FDA recall D-325-2013

Product

ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts.

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-04-01

Report date

2013-05-22

Termination date

2018-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Roscoe, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-325-2013