Botanical Be: Drug Recall

Recall #D-0225-2024 · 10/20/2023

Class I: Dangerous

Recall Details

Recall Number
D-0225-2024
Classification
Class I
Product Type
Drug
Recalling Firm
Botanical Be
Status
Ongoing
Date Initiated
10/20/2023
Location
El Paso, TX, United States
Voluntary/Mandated
Voluntary: Firm initiated

Reason for Recall

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

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

Distribution Pattern

USA Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.