FDA Recall D-1206-2019
Brian P. Richardson · Dallas, TX
Class I — life-threatening Terminated 1020 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
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.
Recall record
- Recall number
D-1206-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2019-04-05
- Classified by FDA Center
- 2019-04-22
- FDA published
- 2019-04-24
- Terminated
- 2022-01-19
- Recalling firm
- Brian P. Richardson
- Firm location
- Dallas, TX