FDA Recall D-0353-2021
Na Na Collection · Elmwood Park, NJ
Class II Ongoing 1871 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 Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
Reason for recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Recall record
- Recall number
D-0353-2021- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide with the United States
- Recall initiated
- 2021-03-30
- Classified by FDA Center
- 2021-04-26
- FDA published
- 2021-05-05
- Recalling firm
- Na Na Collection
- Firm location
- Elmwood Park, 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.