The Recall Desk
CriticalFDA (Drugs)·D-0230-2016·Announced 2015-11-18

Miracle Diet 30 Recalled for Undeclared Phenolphthalein

The One Minute Miracle Inc. is recalling Miracle Diet 30 capsules because they contain undeclared phenolphthalein, an unapproved drug ingredient.

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

The One Minute Miracle Inc. is recalling Miracle Diet 30 capsules, 30-count bottles, manufactured exclusively for the company. The recall covers all lots through the expiration date of 04/15/2018. The product was distributed nationwide.

The FDA identified that the product contains undeclared phenolphthalein. Phenolphthalein is a drug product that was previously contained in over-the-counter laxatives but was removed from the U.S. market due to safety concerns. Because of this undeclared ingredient, the product is considered an unapproved drug marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
Affected units
1

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 through Expiration Date 04/15/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by The One Minute Miracle 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 2 products in this recall →

Same manufacturer · The One Minute Miracle Inc

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