African Black Ant capsules recalled for undeclared sildenafil
Eugene Oregon, Inc. is recalling African Black Ant capsules because FDA laboratory analyses found undeclared sildenafil. The product was marketed without an approved NDA/ANDA.
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 indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death. The presence of undeclared sildenafil in a product marketed without approval is a severe hazard.
Plain-English summary
Eugene Oregon, Inc. is recalling 460 boxes of African Black Ant, 2800 mg, 6 capsules per box. The product was produced by Qinghan Hongwei Bioengineering Company in Xining City. The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
FDA laboratory analyses determined that the capsules contain undeclared sildenafil. Sildenafil is an active pharmaceutical ingredient that can have significant health effects, particularly for individuals taking certain medications. The source text does not specify the number of affected units beyond the 460 boxes or report any specific illnesses or injuries.
The product was distributed to retailers in Maryland, Texas, Florida, Pennsylvania, Illinois, New Jersey, Indiana, Louisiana, Washington, Maine, and South Carolina. Consumers who have purchased this product should stop using it and consult a healthcare professional if they have taken it, especially if they are taking nitrates or other medications that may interact with sildenafil.
The recalled product
- Product
- AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
- Manufacturer
- Eugene Oregon, Inc.
- Category
- Drug — Supplement
- Affected units
- 460
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
Distribution
Part of a larger recall action
This product is one of 3 recalled by Eugene Oregon, 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.
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