The One Minute Miracle Inc. is recalling one lot each of Miracle Diet 30, capsules and Miracle Rock 48.
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 Diet 30 capsules is marketed as a dietary supplement to support appetite control and lose weight and is packaged in 30-count plastic bottles. The affected Miracle Diet 30 Lot Number 150416, Expiration 04/15/2018. Product was distributed via internet nationwide in the United States.
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.
Miracle Rock 48 is 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. The affected Miracle Rock 48 Lot Number 20150602, Expiration 06/01/2018. Product was distributed via internet nationwide in the United States.
These undeclared ingredients make Miracle Diet 30 and Miracle Rock 48 unapproved drugs.
The company has received no reports of illness associated with these products to date.
In addition to the voluntary recall of the above products, The One Minute Miracle Inc. has chosen to withdraw the following products from the marketplace to provide its customers with the certainty of safety. Those products include all sizes and lots of Miracle Cholesterol, Miracle Night Time, Miracle Joint-Flex, Miracle Stud 72, Miracle Magic Man, Male Mint Gum, Miracle 48 Hrs, Miracle Magic Woman, Miracle Cougar, Miracle Cougar Gum, Miracle Cougar G-Spot, Miracle G-Spot, Vagina Rejuvenation, Miracle Anti-Wrinkle, Miracle Stud Delay, Miracle Male Stud Spray, Miracle Male Stud Coffee, Miracle Male Coffee, Male 10, Miracle Male Stud Sublingual, Male 72 Hr, Miracle Tongue Sublingual, Miracle Tongue and Master Blaster.
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 to: The One Minute Miracle Inc. 3322 NE 166 Street, North Miami Beach, FL 33160
Consumers with questions regarding this recall can contact The One Minute Miracle Inc. by phone (305)947-6244 or email firstname.lastname@example.org Monday through Friday, 9:00am through 5:00pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail of by fax. Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm disclaimer icon Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-FDA-0178.
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