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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