FDAFDA · Food and drugs·Recall number D-370-2014
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
Published December 25, 2013 · Recall initiated: October 22, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zi Xiu Tang Success, LLC
- Distributor
- Nationwide and Canada to distributors and consumers.
- Lot
- Lot numbers: 05/25/2012, Exp 05/24/14; 07/29/2012, Exp 07/28/14; and 08/05/2012, Exp 08/04/14
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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