D-0382-2021 Class II Ongoing
FDA drug recall D-0382-2021 was initiated by Hyobin LLC on April 6, 2021 and is designated Class II. Reason for recall: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. The recall status is ongoing. Affected quantity: 500 cards.
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 Black 5000, 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