Samurai-X Honey 6800 Recalled for Undeclared Drug Ingredients
Samurai-X Honey 6800, manufactured by Pyramids Wholesale Inc., is recalled for containing undeclared sildenafil and/or tadalafil. The product was distributed nationwide and marketed without FDA drug approval.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of 4 per the rubric. The product contains undeclared pharmaceutical ingredients marketed without required FDA drug approval.
Plain-English summary
Samurai-X Honey 6800 (UPC 2 56891 27553 3), manufactured by Pyramids Wholesale Inc., is being recalled. The product contains undeclared sildenafil and/or tadalafil.
The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Both substances require FDA approval before being included in products marketed for human consumption.
The recall includes all lots distributed nationwide in the United States. Consumers who have purchased this product should not use it and should consult their healthcare provider if they have consumed the product.
The recalled product
- Product
- Samurai-X Honey 6800, UPC 2 56891 27553 3.
- Manufacturer
- Pyramids Wholesale Inc.
- Category
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Pyramids Wholesale 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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