FDA Recall D-369-2014

Zi Xiu Tang Success, LLC · Kutztown, PA

Class I — life-threatening Terminated 760 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: 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

Quantity: 6084 bottles

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.

Recall record

Recall number: D-369-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide and Canada to distributors and consumers.
Recall initiated: 2012-10-22
Classified by FDA Center: 2013-12-18
FDA published: 2013-12-25
Terminated: 2014-11-21
Recalling firm: Zi Xiu Tang Success, LLC
Firm location: Kutztown, PA

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