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U.S. Department of Health and Human Services

Enforcement Report - Week of May 7, 2014

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Product Detail

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

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
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