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D-0225-2024Class I

Botanical Be

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Botanical Be
Product type
Drug
Status
Ongoing
Report date
2023-12-06
Distribution
USA Nationwide
Firm state
TX
Initiated by
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

Code / lot info

All lots, exp 10/20/2024

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →