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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA. There are no manufacturing codes associated with the product. Class I 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. unknown D-165-2013
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