FDA Recall D-0635-2021
Miracle 8989 · Dallas, TX
Class I — life-threatening Terminated 785 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
Reason for recall
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Recall record
- Recall number
D-0635-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- USA Nationwide
- Recall initiated
- 2021-05-18
- Classified by FDA Center
- 2021-06-22
- FDA published
- 2021-06-30
- Terminated
- 2023-07-12
- Recalling firm
- Miracle 8989
- Firm location
- Dallas, TX