D-1206-2019 Class I Terminated
FDA drug recall D-1206-2019 was initiated by Brian P. Richardson on April 5, 2019 and is designated Class I. 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, ma… The recall status is terminated (terminated January 19, 2022). Affected quantity: 6000 packages.
Recall Details
- Product Type
- Drugs
- Report Date
- April 24, 2019
- Initiation Date
- April 5, 2019
- Termination Date
- January 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6000 packages
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
All Lots labeled with EXP 13 10 2020