Dream Body Slimming Capsule Recalled for Undeclared Sibutramine
Slim Beauty USA is recalling Dream Body Slimming Capsules because they contain undeclared sibutramine, an unapproved new drug not currently marketed in the United States.
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
Slim Beauty USA is recalling Dream Body Slimming Capsules, 350 mg, 30-count bottles, made in China (Beijing). The product contains Chinese bitter orange, Cassia Seed, Aloe, Lotus Leaf Extract, and Medical Amylum. The specific lot number is 20130328, with an expiration date of 3/27/15. The recall is nationwide.
The recall is being conducted because the product contains undeclared sibutramine. Sibutramine is not currently marketed in the United States, which makes this product an unapproved new drug. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
- Manufacturer
- Slim Beauty USA
- Category
- Drug — Dietary Supplement
- Affected units
- 3
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 # 20130328
- Exp 3/27/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Slim Beauty USA 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 →Related recalls
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