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U.S. Department of Health and Human Services

Enforcement Report - Week of May 7, 2014

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Event Detail

Event ID 66817
Product Type Drugs
Status Ongoing
Recalling Firm Deseo Rebajar
City Fajardo
State PR
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-07
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com. Lot #: 052012, Exp 10/2015 Class I Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement. 1,146 bottles D-1277-2014