July 2017 FDA Recall Drug by Bestherbs Coffee Llc
D-1144-2017 - Marketed without an approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Bestherbs Coffee Llc on July 17, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1144-2017

Reason for Recall
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Initiated
07-17-2017
Reported
09-20-2017
Quantity
6,250 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77768
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
BESTHERBS COFFEE LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Recalling firm only distributed to 2 consignees in TX; however recalling firm reported that product is then distributed U.S. nationwide to consumers via individuals or internet
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-10-2018
Product Description About Product Description
Full technical description of the 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]

Batch or Lot Expiration Information

Lot# UPC 557205060083 ,Exp 5/24/18