Status
Terminated
Drug Enforcement D-325-2013
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.
Classification
Class I
Report Date
May 22, 2013
Termination Date
May 10, 2018
Product Information
- Product description
- 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.
- Product 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 initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Consumer Concepts, Inc.
- Address
-
5062 Rock Rose Ct., Suite #40
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-325-2013
- Event ID
- 64838
- Recall initiation date
- April 1, 2013
- Center classification date
- May 16, 2013
- Code info
- All product sold between 01/01/13 through 03/27/13.
- More code info
- —