The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1139-2016·Announced 2016-07-13

Asset extreme+PLUS Capsules Recalled for Undeclared Sibutramine

Bee Extremely Amazed LLC is recalling Asset extreme+PLUS Capsules because the product was found to contain undeclared sibutramine, a withdrawn appetite suppressant.

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 severity score of 5 according to the rubric.

Plain-English summary

Bee Extremely Amazed LLC is recalling Asset extreme+PLUS Capsules, 500 mg, 30-count bottles. The product is distributed by Descor, LLC and marketed as a dietary supplement. The recall covers all lots and is distributed nationwide.

The FDA has determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product was found to be tainted with undeclared sibutramine, an appetite suppressant that was previously withdrawn from the US market for safety reasons. The presence of this substance makes the product an unapproved drug.

Consumers who have purchased Asset extreme+PLUS Capsules should stop using the product immediately. The source text does not provide specific instructions for returning the product or a contact number for the recalling firm.

The recalled product

Product
Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com www.allnaturalbeelievers.com

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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Bee Extremely Amazed 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 14 products in this recall →

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