The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-369-2014·Announced 2013-12-25

Bee Pollen Capsules Recalled for Undeclared Sibutramine

Zi Xiu Tang Success, LLC is recalling Classic Zi Xiu Tang Bee Pollen Capsules because they contain undeclared sibutramine, an unapproved active ingredient.

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 FDA classifies this recall as Class I, which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

Zi Xiu Tang Success, LLC is voluntarily recalling Classic Zi Xiu Tang Bee Pollen Capsules (250 mg x 60 capsules per bottle) due to the presence of undeclared sibutramine. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Sibutramine is the active ingredient in a previously approved FDA product indicated for weight loss that was removed from the market for safety reasons.

The recall involves 6,084 bottles distributed nationwide and in Canada to distributors and consumers. Affected lot numbers include 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). The product is identified by UPC 6 937000 700019.

Consumers should stop using the product and contact the distributor for further instructions. The FDA classifies this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

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
Manufacturer
Zi Xiu Tang Success, LLC
Category
Drug — Dietary Supplement
Hazard
Affected units
6,084

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 (8)

  • 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

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 →

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