D-0230-2016 Class I Ongoing

Recalled by The One Minute Miracle Inc — North Miami Beach, FL

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