vitaliKOR Dietary Supplement Recalled for Undeclared Prescription Ingredients
Vitality Research Labs is recalling vitaliKOR capsules because FDA sampling found undeclared vardenafil and tadalafil. The product was marketed without an approved NDA or ANDA.
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 indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.
Plain-English summary
Vitality Research Labs, LLC is recalling vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules. The recall involves 11,523 bottles of lot K58Q (expiration 01/16) and 54,255 bottles of lot F50Q (expiration 07/16). The product was distributed nationwide.
The FDA initiated this recall after sampling revealed the presence of undeclared vardenafil and tadalafil in the capsules. These are prescription medications that were not listed on the product label. The agency noted that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who possess these specific lots of vitaliKOR capsules should stop using the product and contact Vitality Research Labs, LLC for further instructions or a refund. The presence of undeclared prescription ingredients in a dietary supplement poses significant health risks, particularly for individuals with certain medical conditions or those taking other medications.
The recalled product
- Product
- vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.
- Manufacturer
- Vitality Research Labs LLC
- Category
- Drug — Dietary Supplement
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)
- LOT K58Q Exp 01/16 LOT F50Q Exp 07/16
Distribution
Distributed nationwide across the United States.
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