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Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de C...

FDA Recall #D-0225-2024 — Class I — October 20, 2023

Recall #D-0225-2024 Date: October 20, 2023 Classification: Class I Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Botanical Be — El Paso, TX

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Distribution

USA Nationwide

Code Information

All lots, exp 10/20/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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