FDA Recalls New Kopi Jantan Coffee for Undeclared Ingredients
Bestherbs Coffee LLC is recalling New Kopi Jantan coffee packets because they contain undeclared desmethyl carbodenafil and milk.
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 meets the rubric criteria for a Critical severity score.
Plain-English summary
Bestherbs Coffee LLC is recalling 6,250 packets of New Kopi Jantan Tradisional Natural Herbs Coffee. The product is packaged in 13-gram red packets, with 25 packets per box, and was manufactured in Malaysia. The specific lot has a UPC of 557205060083 and an expiration date of 5/24/18.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared desmethyl carbodenafil and undeclared milk. The presence of undeclared milk poses a risk to consumers with milk allergies, while the undeclared drug ingredient poses risks to consumers with certain medical conditions or those taking specific medications.
The recalling firm distributed the product to two consignees in Texas. However, the firm reported that the product was subsequently distributed nationwide to consumers via individuals or the internet. Consumers who have this product should stop using it and contact the distributor for further instructions.
The recalled product
- Product
- New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: [email protected]
- Manufacturer
- BESTHERBS COFFEE LLC
- Category
- Food — Coffee / Herbal Beverage
- Affected units
- 6,250
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 (2)
- UPC 557205060083
- Exp 5/24/18
Distribution
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