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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Recall Number D-1370-2014
Classification Class I
Code Info lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12
Product Distributed Qty unknown
Reason For Recall Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

Event Detail

Event Id 67810
Product Type Drugs
Status Ongoing
Recalling Firm Pure Edge Nutrition
City Toms River
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-10
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide