Drug product
MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
D-0230-2016
Product summary
- 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
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.