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Recall Observatory FDA recall evidence

Drug product

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

D-0230-2016

August 27, 2015

Class I

Product summary

Firm
The One Minute Miracle Inc
Event
Event 72058
Status
Ongoing
Classification
Class I
Quantity
1 bottle
Official record key
drug-enforcement:D-0230-2016

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.

Code information: All lots through Expiration Date 04/15/2018

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.