FDA Recall D-325-2013

Consumer Concepts, Inc. · Roscoe, IL

Class I — life-threatening Terminated 1865 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: All product sold between 01/01/13 through 03/27/13.

Quantity: 11,424 blister packs

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.

Recall record

Recall number: D-325-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide
Recall initiated: 2013-04-01
Classified by FDA Center: 2013-05-16
FDA published: 2013-05-22
Terminated: 2018-05-10
Recalling firm: Consumer Concepts, Inc.
Firm location: Roscoe, IL

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