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.
Product description
MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
Lot numbers, UPCs & expiration codes
All lots through Expiration Date 04/15/2018
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0230-2016
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 27, 2015
- FDA report date
- Nov 18, 2015
- Quantity
- 1 bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The One Minute Miracle Inc
Original FDA data
Every field from FDA enforcement report D-0230-2016, exactly as published.
Show all FDA fields
- City
- North Miami Beach
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 72058
- Address
- 3322 NE 166th St
- Code information
- All lots through Expiration Date 04/15/2018
- Postal code
- 33160-3844
- Report date
- Nov 18, 2015
- Product type
- Drugs
- Recall number
- D-0230-2016
- Classification
- Class I
- Recalling firm
- The One Minute Miracle Inc
- Product quantity
- 1 bottle
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 27, 2015
- Initial firm notification
- Center classification date
- Nov 12, 2015