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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
Recall Number D-370-2014
Classification Class I
Code Info Lot numbers: 05/25/2012, Exp 05/24/14; 07/29/2012, Exp 07/28/14; and 08/05/2012, Exp 08/04/14
Product Distributed Qty 16126 bottles
Reason For Recall Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.

Event Detail

Event Id 63525
Product Type Drugs
Status Ongoing
Recalling Firm Zi Xiu Tang Success, LLC
City Kutztown
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Canada to distributors and consumers.
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