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Recall Observatory FDA recall evidence

Drug 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.

D-325-2013

April 01, 2013

Class I

Product summary

Firm
Consumer Concepts, Inc.
Event
Event 64838
Status
Terminated
Classification
Class I
Quantity
11,424 blister packs
Official record key
drug-enforcement:D-325-2013

Official wording

Reason: 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.

Code information: All product sold between 01/01/13 through 03/27/13.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.