Dallas, TX, United States
Brian P. Richardson recalls
1 recall recorded since 2018, most recently on 5 April 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 5 April 2019
- Terminated
- 19 January 2022
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1206-2019
- Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.