Miracle Rock 48 capsules recalled for containing undeclared thiosildenafil
The One Minute Miracle Inc. is recalling Miracle Rock 48 capsules because they contain undeclared thiosildenafil, an unapproved drug analogue.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
The One Minute Miracle Inc. is recalling Miracle Rock 48 capsules, which are packaged in 2 x 2-count blisters with 4-count capsules per carton. The product is identified by UPC 0911312397354. The recall covers 688 cartons distributed nationwide, including all lots through the expiration date of 06/01/2018.
The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules were found to contain undeclared thiosildenafil, which is an analogue of an FDA-approved drug for male erectile dysfunction. This makes the product an unapproved drug.
Consumers who have purchased this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- The One Minute Miracle Inc
- Category
- Drug — Unapproved Drug
- Affected units
- 688
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots through Expiration Date 06/01/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by The One Minute Miracle Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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