Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
FDA Recall #D-0626-2024 — Class I — July 18, 2024
Product Description
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.
Recalling Firm
MAIN PRODUCTS INC — Chula Vista, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
57, 340 bottles
Distribution
Nationwide within the U.S
Code Information
All lots within expiry
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated