Home / Recalls / Botanical Be / D-0225-2024

D-0225-2024 Class I Ongoing

Recalled by Botanical Be — El Paso, TX

Recall Details

Product Type: Drugs
Report Date: December 6, 2023
Initiation Date: October 20, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

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.

Distribution Pattern

USA Nationwide

Code Information

All lots, exp 10/20/2024