FDA Recall D-0620-2024

SoloVital · Chula Vista, CA

Class I — life-threatening Ongoing 671 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: All lots within Expiry

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 record

Recall number: D-0620-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide within the United States
Recall initiated: 2024-07-12
Classified by FDA Center: 2024-07-29
FDA published: 2024-08-07
Recalling firm: SoloVital
Firm location: Chula Vista, CA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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