D-370-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2013
- Initiation Date
- October 22, 2012
- Termination Date
- November 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16126 bottles
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
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 Pattern
Nationwide and Canada to distributors and consumers.
Code Information
Lot numbers: 05/25/2012, Exp 05/24/14; 07/29/2012, Exp 07/28/14; and 08/05/2012, Exp 08/04/14