D-0381-2021 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 26, 2021
- Initiation Date
- April 6, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 cards
Product Description
PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Reason for Recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Distribution Pattern
USA Nationwide
Code Information
all lots