Lite Fit USA Recalled for Undeclared Sibutramine
Bacai, Inc. is voluntarily recalling Lite Fit USA supplements containing undeclared sibutramine, making them unapproved new drugs.
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 source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to the presence of undeclared sibutramine. The product is marketed as an extreme fat burner and appetite suppressant. The recall is being conducted because the undeclared ingredient makes the product an unapproved new drug.
The affected product consists of 14,040 softgel capsules distributed worldwide via internet sales. The specific lot number is 13165, with an expiration date of 05/17. The product is distributed by Bacai, INC. and can be found at www.litefitusa.com.
Consumers who have purchased this product should stop using it immediately. The presence of undeclared sibutramine poses a risk to consumer health as it is a controlled substance with potential for serious adverse effects, including cardiovascular issues. The FDA classifies this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com
- Manufacturer
- Bacai Inc. Dba Ky Duyen House
- Category
- Drug — Dietary Supplement
- Affected units
- 14,040
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 (2)
- Lot #13165
- Exp. 05/17
Distribution
Distribution scope not specified by the agency.
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