The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1700-2012·Announced 2012-10-03

Japan Weight Loss Blue Capsules Recalled for Unapproved Sibutramine

Vitaminbestbuy.com is recalling Japan Weight Loss Blue Capsules because they contain sibutramine, an unapproved drug 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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Vitaminbestbuy.com is recalling 52 boxes of Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box. The product is described as a green algae lipotropic (fat dissolving) agent and was distributed nationwide.

The recall was initiated because the product was marketed without an approved ANDA/NDA and contains sibutramine. Sibutramine is a drug ingredient that was not approved for use in this over-the-counter product.

Consumers who have purchased this product should stop using it and contact the distributor for further instructions.

The recalled product

Product
Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
Affected units
52

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 3 recalled by www.vitaminbestbuy.com 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 3 products in this recall →

Same manufacturer · www.vitaminbestbuy.com

See all →

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