D-0641-2021 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 7, 2021
- Initiation Date
- April 8, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2600 capsules
Product Description
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
Reason for Recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Distribution Pattern
USA Nationwide
Code Information
all lots