FDA Drug Class I — Most Serious

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

Hazard

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

Products

Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
Brand
Botanical Be
UPC
All lots, exp 12/12/2024

Units Affected

300 bottles