MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
FDA recall notice · announced November 18, 2015 · The One Minute Miracle
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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.
Notes
Distribution: Nationwide
Lot/code information: All lots through Expiration Date 04/15/2018
Quantity: 1 bottle
Status: Ongoing
Products in this recall event:
- MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354. (D-0229-2016)
- MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768. (D-0230-2016)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.