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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 All Lots All codes. Class I Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. unknown D-038-2013
Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066 All Lots All codes. Class I Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. unknown D-039-2013
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