FDA-Drug2013-05-22Class I
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.
Consumer Concepts, Inc.
Hazard
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.
Sold states
Nationwide
Affected count
11,424 blister packs
Manufactured in
5062 Rock Rose Ct., Suite #40, Roscoe, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-325-2013Don't want to check this manually?
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