drugs Class I Updated 2013-05-22

Consumer Concepts, Inc. recalls ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-c

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All product sold between 01/01/13 through 03/27/13.
View official government recall

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