Jenesis Capsules Recalled for Undeclared Sibutramine and Phenolphthalein
Bee Extremely Amazed LLC is recalling Jenesis Capsules marketed as a dietary supplement because they contain undeclared sibutramine and phenolphthalein, both withdrawn from the US market for safety reasons.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Bee Extremely Amazed LLC is recalling 79 bottles of Jenesis Capsules, 350 mg, 60-count bottles, manufactured for Timeless Solutions. The product was marketed nationwide as a dietary supplement without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The FDA determined that the product is tainted with undeclared sibutramine, an appetite suppressant withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxatives withdrawn due to concerns of carcinogenicity. The presence of these ingredients makes the product an unapproved drug.
Consumers who have purchased Jenesis Capsules should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104
- Manufacturer
- Bee Extremely Amazed LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 79
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 14 recalled by Bee Extremely Amazed LLC 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.
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