Class I
Terminated
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
- Company
- Zi Xiu Tang Success, Llc
- Recall Initiated
- October 22, 2012
- Posted
- December 25, 2013
- Recall Number
- D-370-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16126 bottles
- Firm Location
- Kutztown, PA, United States
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.
Distribution
Nationwide and Canada to distributors and consumers.
Lot / 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
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