The Recall Desk
CriticalFDA (Drugs)·D-1377-2014·Announced 2014-06-18

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.

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 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.
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.

See all 10 products in this recall →