Drug Enforcement D-0620-2024

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

Status

Ongoing

Classification

Class I

Report Date

August 7, 2024

Termination Date

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Product Information

Product description
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Product quantity
1,331 bottles
Reason for recall
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
SoloVital
Address
2571 Mast Way, #203

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

Codes & Dates

Recall number
D-0620-2024
Event ID
94978
Recall initiation date
July 12, 2024
Center classification date
July 29, 2024
Code info
All lots within Expiry
More code info
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