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.
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 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.
- Manufacturer
- The One Minute Miracle Inc
- Category
- Drug — Dietary Supplement
- 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.
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