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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Product Detail

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
Recall Number D-038-2013
Classification Class I
Code Info All Lots All codes.
Product Distributed Qty unknown
Reason For Recall Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.

Event Detail

Event Id 62543
Product Type Drugs
Status Ongoing
Recalling Firm Coral Rock Man, Inc.
City Key Colony Beach
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-16
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.