Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, L...
FDA Recall #D-370-2014 — Class I — October 22, 2012
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.
Recalling Firm
Zi Xiu Tang Success, LLC — Kutztown, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
16126 bottles
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated