Vitility Recalls MAN OF STEEL Capsules Containing Undeclared Sildenafil
Vitility is recalling MAN OF STEEL capsules because FDA analysis found they contain undeclared sildenafil, an unapproved drug with unestablished safety and efficacy.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Vitility is recalling MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, packaged for One Drop Solutions, LLC. The product is distributed nationwide in the USA. The recall involves 75 packets labeled with an expiration date of 10-17-2018 and no lot number.
The U.S. Food and Drug Administration (FDA) initiated this recall because FDA analysis found the product contains undeclared sildenafil. Sildenafil is an FDA-approved drug for the treatment of erectile dysfunction. Because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is considered an unapproved drug for which safety and efficacy have not been established.
Consumers who have purchased MAN OF STEEL capsules should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; [email protected]; www.manofsteelpills.com; UPC 1 0001001378 7.
- Manufacturer
- Vitility
- Category
- Drug — Supplement
- Affected units
- 75
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)
- No Lot #: labeled Expires: 10-17-2018
Distribution
Distributed nationwide across the United States.
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