FDA recall D-0626-2024

MAIN PRODUCTS INC · Class I · drug

Product

Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

Reason for recall

Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.

Distribution

Nationwide within the U.S

Key facts

Status
Ongoing
Initiation date
2024-07-18
Report date
2024-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chula Vista, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0626-2024