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Recall Observatory FDA recall evidence

Drug 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

D-369-2014

October 22, 2012

Class I

Product summary

Firm
Zi Xiu Tang Success, LLC
Event
Event 63525
Status
Terminated
Classification
Class I
Quantity
6084 bottles
Official record key
drug-enforcement:D-369-2014

Official wording

Reason: 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.

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

Distribution pattern: Nationwide and Canada to distributors and consumers.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.