FDA recall D-0226-2024

Botanical Be · Class I · drug

Product

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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2023-10-20
Report date: 2023-12-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0226-2024