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. |
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