D-0383-2021 Class II Ongoing
FDA drug recall D-0383-2021 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: 300 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
- 300 cards
Product Description
Triple SupremeZen Plus 3500, 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