PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: December 6, 2023 Initiated: October 20, 2023 #D-0226-2024

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.

Details

Recalling Firm
Botanical Be
Units Affected
300 bottles
Distribution
USA Nationwide
Location
El Paso, TX

Frequently Asked Questions

What product was recalled?
Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265. Recalled by Botanical Be. Units affected: 300 bottles.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 6, 2023. Severity: Critical. Recall number: D-0226-2024.