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D-0226-2024Class 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
Product quantity
300 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265

Code / lot info

All lots, exp 12/12/2024

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

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 →