Drug product
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
D-0620-2024
Product summary
- Firm
- SoloVital
- Event
- Event 94978
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1,331 bottles
- Official record key
drug-enforcement:D-0620-2024
Official wording
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Code information: All lots within Expiry
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.