D-0351-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 5, 2021
- Initiation Date
- March 25, 2021
- Termination Date
- July 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
Reason for Recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Distribution Pattern
Nationwide within the United States
Code Information
All lots within expiry