D-0230-2016 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 18, 2015
- Initiation Date
- August 27, 2015
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 bottle
Product Description
MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
All lots through Expiration Date 04/15/2018