FDAFDA · Food and drugs·Recall number D-369-2014
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
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: 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
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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