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U.S. Department of Health and Human Services

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