Slim Expert Softgels Recalled for Undeclared Sibutramine
B @ B Trade Inc. is recalling Slim Expert softgels because they contain undeclared sibutramine and were marketed without FDA approval.
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
B @ B Trade Inc. is recalling Slim Expert softgel capsules, a dietary supplement sold as a one-month supply of 30 softgels. The recall involves 10 bottles distributed nationwide, covering all lots.
The FDA is recalling this product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product was found to contain undeclared sibutramine, a substance not listed on the label.
Consumers who have purchased this product should stop using it immediately. The recall is nationwide, and all lots are affected.
The recalled product
- Product
- Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.
- Manufacturer
- B @ B Trade Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 10
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 B @ B Trade Inc. 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
Same manufacturer · B @ B Trade Inc.
See all →- CriticalSlim Fortune capsules recalled for undeclared sibutramine
FDA (Drugs) · 2014-04-23
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FDA (Drugs) · 2014-04-23
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