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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 For Men, Dietary Supplement, Directions: Take one capsule 1-2 hours prior to intimacy. Made In The USA, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
Recall Number D-037-2013
Classification Class I
Code Info UPC 0 00309 50792 7 All Lots
Product Distributed Qty 215,000 capsules
Reason For Recall Marketed Without an Approved NDA/ANDA: Product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).

Event Detail

Event Id 61669
Product Type Drugs
Status Ongoing
Recalling Firm XRock Industries, LLC
City Pompano Beach
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-21
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Products were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom.
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