ISSUE: The One Minute Miracle Inc. is voluntarily recalling all lots of Miracle Diet 30, capsules and Miracle Rock 48, capsules to the consumer level. These products have been recalled due to FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.
Miracle Diet 30 has been found to contain undeclared phenolphthalein, phenolphthalein was an ingredient used in over-the counter laxatives but was removed from the market because of concerns of carcinogenicity. There is a reasonable probability that the health risks of long term phenolphthalein consumption could include serious gastrointestinal disturbances, irregular heartbeat, and cancer with long term use.
Miracle Rock 48 has been found to contain undeclared thiosildenafil, thiosildenafil is an analogue of sildenafil which is an approved drug used for the treatment of male sexual enhancement. Based on the similarity of chemical structures thiosildenafil, the analogue of sildenafil is likely to have a similar pharmacological effect as sildenafil and there is a reasonable probability that concomitant use of this dietary supplement and nitrates could cause a sudden and significant drop in blood pressure that may be life threatening.
BACKGROUND: The company has received no reports of illness associated with these products to date.
Miracle Diet 30 capsules is marketed as a dietary supplement to support appetite control and weight loss and is packaged in 30-count plastic bottles. All lots of Miracle Diet 30 through the expiration date of 04/15/2018 are affected. Product was distributed via internet nationwide in the United States.
Miracle Rock 48 capsules is marketed as a dietary supplement for male sexual enhancement and is packaged in two blister packages of 2- count capsules, 4 capsules per box. All lots of Miracle Rock 48 through the expiration date of 06/01/2018 are affected. Product was distributed via nationwide in the United States.
In addition to the voluntary recall of the above products, The One Minute Miracle Inc. has chosen to voluntarily withdraw the following products from the marketplace to provide its customers with the certainty of safety, for additional products see the Firm Press Release.
RECOMMENDATION: The One Minute Miracle is notifying its customers via U.S. Postal Service and is arranging for return of recalled products. Consumers that have Miracle Diet 30 and/or Miracle Rock 48 which are being recalled should stop using and return product(s) immediately.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.