Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Orteg...
FDA Recall #D-0226-2024 — Class I — October 20, 2023
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
Reason for Recall
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Recalling Firm
Botanical Be — El Paso, TX
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
300 bottles
Distribution
USA Nationwide
Code Information
All lots, exp 12/12/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated