Agency classClass IOur severity:Critical FDA (Drugs)·D-370-2014·Announced 2013-12-25

Zi Xiu Tang Ultimate Formula Recalled for Undeclared Sibutramine

Zi Xiu Tang Success, LLC is recalling Ultimate Formula capsules because they contain undeclared sibutramine, an ingredient removed from the market for safety reasons.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4, and the presence of a known dangerous, withdrawn active ingredient (sibutramine) in an unapproved drug elevates the risk to Critical.

Plain-English summary

Zi Xiu Tang Success, LLC is voluntarily recalling approximately 16,126 bottles of Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle. The product was distributed nationwide and in Canada to distributors and consumers. The recall involves three specific lot numbers: 05/25/2012 (Exp 05/24/14), 07/29/2012 (Exp 07/28/14), and 08/05/2012 (Exp 08/04/14).

The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing revealed that the capsules contain undeclared sibutramine. Sibutramine is the active ingredient in a previously approved FDA product indicated for weight loss, but it was removed from the market for safety reasons. Consequently, the FDA classifies these products as unapproved new drugs.

Consumers who have purchased this product should stop using it immediately. They should contact Zi Xiu Tang Success, LLC for further instructions on how to return the product or obtain a refund.

The recalled product

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
Manufacturer: Zi Xiu Tang Success, LLC
Category: Drug — Dietary Supplement
Hazard: undeclared-ingredient
sibutramine
unapproved-drug
Affected units: 16,126

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zi Xiu Tang Success, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Zi Xiu Tang Success, LLC

See all →

Critical
Bee Pollen Capsules Recalled for Undeclared Sibutramine
FDA (Drugs) · 2013-12-25

Same hazard · undeclared ingredient