D-325-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2013
- Initiation Date
- April 1, 2013
- Termination Date
- May 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,424 blister packs
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.
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.
Distribution Pattern
Nationwide
Code Information
All product sold between 01/01/13 through 03/27/13.