FDA Recall D-0626-2024

MAIN PRODUCTS INC · Chula Vista, CA

Class I — life-threatening Ongoing 665 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: 57, 340 bottles

Reason for recall

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

Recall record

Recall number: D-0626-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the U.S
Recall initiated: 2024-07-18
Classified by FDA Center: 2024-08-05
FDA published: 2024-08-14
Recalling firm: MAIN PRODUCTS INC
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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