PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: December 6, 2023 Initiated: October 20, 2023 #D-0225-2024

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.

Details

Recalling Firm
Botanical Be
Distribution
USA Nationwide
Location
El Paso, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Botanical Be.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 6, 2023. Severity: Critical. Recall number: D-0225-2024.