FDA Recall D-0382-2021
Hyobin LLC · Ridgewood, NJ
Class II Ongoing 1864 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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.
Recall record
- Recall number
D-0382-2021- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- USA Nationwide
- Recall initiated
- 2021-04-06
- Classified by FDA Center
- 2021-05-14
- FDA published
- 2021-05-26
- Recalling firm
- Hyobin LLC
- Firm location
- Ridgewood, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.