Slim Xtreme Weight Loss Capsules Recalled for Undeclared Sibutramine Ingredients
MyNicNaxs, Inc. is recalling Slim Xtreme Weight loss capsules because they contain undeclared active pharmaceutical ingredients, including sibutramine, and were marketed without FDA approval.
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
MyNicNaxs, Inc. is recalling Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles. The product is manufactured by Globe All Wellness, LLC and distributed by MyNicKnaxs, LLC. The recall covers all lots of the product.
The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine.
Consumers who have purchased this product should stop using it immediately and contact the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL
- Manufacturer
- MyNicNaxs, Inc.
- Category
- Drug — Weight Loss Supplement
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 10 recalled by MyNicNaxs, 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.
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