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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1 Lot numbers: 05/25/2012, Exp 05/24/14; 07/29/2012, Exp 07/28/14; and 08/05/2012, Exp 08/04/14 Class I 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. 16126 bottles D-370-2014
Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 6 937000 700019 Lot numbers: 04/15/2012, Exp 04/15/14; 05/15/2012, Exp 05/15/14; 06/15/2012, Exp 06/15/14; and 07/15/2012, Exp 07/15/14 Class I 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. 6084 bottles D-369-2014
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