Herbal Coffee Recalled for Undeclared Erectile Dysfunction Drugs
The FDA is recalling Kopi Jantan Tradisional Natural Herbs Coffee because it contains undeclared sildenafil and tadalafil, unapproved drugs for erectile dysfunction.
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 mandates a severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages. The product was manufactured by Fikrysz (M) Sdn. Bhd. in Kedah, Malaysia, and marketed by Brian P. Richardson. The recall involves 6,000 packages distributed nationwide in the USA. All affected lots are labeled with an expiration date of 13 10 2020.
The FDA analysis found that the product is tainted with undeclared sildenafil and tadalafil. These are FDA-approved drugs used to treat male 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 this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
- Manufacturer
- Brian P. Richardson
- Category
- Drug — Unapproved Drug
- Affected units
- 6,000
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 labeled with EXP 13 10 2020
Distribution
Distributed nationwide across the United States.
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