Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by:...
FDA Recall #D-369-2014 — Class I — October 22, 2012
Product Description
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
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
6084 bottles
Distribution
Nationwide and Canada to distributors and consumers.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated