Thumbs Up 7 Black 25K Capsules Recalled for Undeclared Tadalafil
Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules nationwide because they contain undeclared tadalafil, an FDA-approved drug. The product was marketed without required approval, making it 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: This recall is classified as FDA Class I. Per the severity rubric, FDA Class I recalls are scored as Critical (5) regardless of other factors, as they represent the most serious safety hazard.
Plain-English summary
Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules in all lots within expiry, distributed nationwide. The capsules are packaged in 1-count blister cards and 10-count boxes.
The product was found to be tainted with undeclared tadalafil, an FDA-approved drug. Because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is classified as an unapproved drug for which safety and efficacy have not been established.
Consumers who have purchased this product should stop using it and consult a healthcare provider with questions about their health or potential exposure.
The recalled product
- Product
- Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
- Manufacturer
- Nuri Trading LLC
- Category
- Drug — Unapproved Drug
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 within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Nuri Trading LLC 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.
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