Slim Beauty USA Recalls Magic Slim Capsules Containing Unapproved Ingredients
Slim Beauty USA is recalling Magic Slim capsules nationwide because they contain undeclared sibutramine and phenolphthalein, 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 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 Magic Slim capsules, 60-count bottles, nationwide. The product contains undeclared sibutramine and phenolphthalein. Because these ingredients are not currently marketed in the United States, the product is considered an unapproved new drug.
The recall is due to the product being marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The presence of undeclared sibutramine and phenolphthalein renders the product an unapproved new drug.
Consumers who have purchased Magic Slim capsules should stop using the product and contact Slim Beauty USA for further instructions. The packaging does not contain lot code information or expiration dates.
The recalled product
- Product
- Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles.
- Manufacturer
- Slim Beauty USA
- Category
- Drug — Dietary Supplement
- Affected units
- 2
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)
- No lot code information or exp date on packaging.
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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FDA (Drugs) · 2014-04-16
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