The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0675-2016·Announced 2016-02-24

Inaffit Recalls Natureal Burn Fat Nature Due to Undeclared Sibutramine

Inaffit, LLC is recalling Natureal Burn Fat Nature capsules because the product contains undeclared sibutramine and was marketed without an approved NDA or ANDA.

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 per the rubric mandates a score of 5 (Critical) regardless of other factors, as it poses a reasonable probability of serious adverse health consequences or death.

Plain-English summary

Inaffit, LLC is recalling 6,000 bottles of Natureal Burn Fat Nature, 30-count capsules, packaged in clear plastic bottles. The product was distributed nationwide. The recall affects all lots of the product.

The FDA identified that the product contains undeclared sibutramine. Additionally, the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Sibutramine is a drug that was withdrawn from the US market due to safety concerns, and its presence in a dietary supplement is a significant safety issue.

Consumers who have purchased Natureal Burn Fat Nature capsules should stop using the product immediately. They should contact Inaffit, LLC for further instructions on how to return the product or obtain a refund.

The recalled product

Product
NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
Manufacturer
Inaffit, LLC
Affected units
6,000

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.

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