Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746 |
|---|---|
| Recall Number | D-1657-2012 |
| Classification | Class I |
| Code Info | Lot #s: a) 101108, 101009, 101010, 101011; b) 101108, 101109, 101110; c) 301000, 301001 |
| Product Distributed Qty | 585,000 Capsules |
| Reason For Recall | Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs. |
Event Detail
| Event Id | 61957 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | The Menz Club, LLC |
| City | Ridgeland |
| State | MS | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-25 |
| Initial Firm Notification of Consignee or Public | Press Release |
| Distribution Pattern | Nationwide |
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