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Recall Observatory FDA recall evidence

Drug product

Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1

D-370-2014

October 22, 2012

Class I

Product summary

Firm
Zi Xiu Tang Success, LLC
Event
Event 63525
Status
Terminated
Classification
Class I
Quantity
16126 bottles
Official record key
drug-enforcement:D-370-2014

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: 05/25/2012, Exp 05/24/14; 07/29/2012, Exp 07/28/14; and 08/05/2012, Exp 08/04/14

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.