Recalls for ‘supplement’ with hidden Viagra API

By Fiona BARRY contact

- Last updated on GMT

Miracle Diet 30 capsules contained a banned laxative
Miracle Diet 30 capsules contained a banned laxative

Related tags: Food and drug administration

A Florida company is recalling 26 sexual enhancement and diet pills after the US FDA discovered some contain undeclared active pharmaceutical ingredients (APIs).

The One Minute Miracle Inc. voluntarily withdrew its male sex supplement Miracle Rock 48 when FDA tests showed it contains thiosildenafil, a synthetic analogue of sildenafil, the active ingredient in Pfizer’s erectile dysfunction drug Viagra.

The US Food and Drug Administration said based on the similarity of chemical structures between sildenafil and its analogue, Miracle Rock 48 is likely to have similar effects to Viagra, 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 marketed as a dietary supplement for male sexual enhancement but because of its undeclared ingredient is in fact an unapproved drug, according to the FDA. The product is packaged in two blister packages, with 4 capsules per box. All lots of Miracle Rock 48 until the expiration date of 06/01/2018 are affected.

Diet pills

The One Minute Miracle also recalled Miracle Diet 30, marketed as a weight loss and appetite control supplement. FDA analysis revealed the pills contain undeclared phenolphthalein, an ingredient once used in over-the counter laxatives but removed from the market because of carcinogenicity risk.

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,​” said the FDA.

The dietary supplements are packaged in 30-count plastic bottles. The recall affects all lots until the expiration date of 04/15/2018.

The company has so far received no reports of illness associated with either product. Both were sold and distributed throughout the US via the internet.

As well as Miracle Rock 48 and Miracle Diet 30, The One Minute Miracle said it has chosen to voluntarily withdraw dozens of other supplements from the market, “to provide its customers with the certainty of safety.​” All sizes and lots of the following will be withdrawn:

  • 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,
  • Master Blaster.

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