FDA recall D-0225-2024

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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2023-10-20

Report date

2023-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0225-2024