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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Recall Number D-921-2013
Classification Class I
Code Info Lot #: 120514, EXP: 12/2014
Product Distributed Qty 18,678 bottles
Reason For Recall Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.

Event Detail

Event Id 65441
Product Type Drugs
Status Ongoing
Recalling Firm Bethel Nutritional Consulting, Inc
City New York
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide. Product was also available for sale via internet