D-0369-2021 Class II Ongoing
FDA drug recall D-0369-2021 was initiated by QMart on March 31, 2021 and is designated Class II. Reason for recall: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. The recall status is ongoing. Affected quantity: 500 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 12, 2021
- Initiation Date
- March 31, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 boxes
Product Description
PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
Reason for Recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Distribution Pattern
USA Nationwide
Code Information
All