FDA recall D-0230-2016

Product

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

Nationwide

Key facts

Status

Ongoing

Initiation date

2015-08-27

Report date

2015-11-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Miami Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2016