Drug Enforcement D-0626-2024

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

Status

Ongoing

Classification

Class I

Report Date

August 14, 2024

Termination Date

—

Product Information

Product description
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Product quantity
57, 340 bottles
Reason for recall
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the U.S

Location & Firm

Recalling firm
MAIN PRODUCTS INC
Address
1551 Glenwood Springs Ave

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0626-2024
Event ID
94962
Recall initiation date
July 18, 2024
Center classification date
August 5, 2024
Code info
All lots within expiry
More code info
—