Drug product
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
D-0626-2024
Product summary
- Event
- Event 94962
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 57, 340 bottles
- Official record key
drug-enforcement:D-0626-2024
Official wording
Reason: Marketed without 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 U.S
Derived failure modes
-
Unknown
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.