FDA Recall D-0225-2024

Botanical Be · El Paso, TX

Class I — life-threatening Ongoing 937 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

Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598

Lot / code: All lots, exp 10/20/2024

Reason for recall

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

Recall record

Recall number: D-0225-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: USA Nationwide
Recall initiated: 2023-10-20
Classified by FDA Center: 2024-01-12
FDA published: 2023-12-06
Recalling firm: Botanical Be
Firm location: El Paso, TX

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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