FDAFDA · Food and drugs·Recall number D-325-2013
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.
Published May 22, 2013 · Recall initiated: April 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Consumer Concepts, Inc.
- Distributor
- Nationwide
- Lot
- All product sold between 01/01/13 through 03/27/13.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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