Class I
Terminated
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
This recall has been terminated (originally issued April 24, 2019).
- Company
- Brian P. Richardson
- Recall Initiated
- April 5, 2019
- Posted
- April 24, 2019
- Recall Number
- D-1206-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6000 packages
- Firm Location
- Dallas, TX, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Distribution
Nationwide in the USA
Lot / Code Info
All Lots labeled with EXP 13 10 2020
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