MIRACLE DIET 30 capsules recalled over undeclared phenolphthalein

Recall date

August 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The One Minute Miracle Inc recalls MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 53807351676…

Recall number

D-0230-2016

FDA classification

Class I

Brand / firm

The One Minute Miracle Inc

Sold / distributed

Nationwide

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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