Meizi Evolution Soft Gel Capsules Recalled for Undeclared Active Ingredients
MyNicNaxs, Inc. is recalling Meizi Evolution Soft Gel Capsules because the product was marketed without an approved NDA/ANDA and contains undeclared active pharmaceutical ingredients.
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 per the rubric.
Plain-English summary
MyNicNaxs, Inc. is recalling Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles and distributed by MyNicKnaxs, LLC in Deltona, FL. The recall involves 5 bottles distributed nationwide, covering all lots.
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 possess these products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL
- Manufacturer
- MyNicNaxs, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 5
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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