Drug product
Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
D-0641-2021
Product summary
- Event
- Event 87712
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2600 capsules
- Official record key
drug-enforcement:D-0641-2021
Official wording
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Code information: all lots
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil