D-038-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 7, 2012
- Initiation Date
- July 16, 2012
- Termination Date
- November 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida
Reason for Recall
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Distribution Pattern
Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
Code Information
All Lots All codes.