Enforcement Report - Week of February 27, 2013
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Product Detail
| Product Description | SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA. |
|---|---|
| Recall Number | D-165-2013 |
| Classification | Class I |
| Code Info | There are no manufacturing codes associated with the product. |
| Product Distributed Qty | unknown |
| Reason For Recall | Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug. |
Event Detail
| Event Id | 63942 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | P & J Trading Co |
| City | Fullerton |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-19 |
| Initial Firm Notification of Consignee or Public | Press Release |
| Distribution Pattern | Nationwide and Korea |
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