D-369-2014 Class I Terminated
FDA drug recall D-369-2014 was initiated by Zi Xiu Tang Success, LLC on October 22, 2012 and is designated Class I. 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 … The recall status is terminated (terminated November 21, 2014). Affected quantity: 6084 bottles.
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
- 6084 bottles
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.
Distribution Pattern
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