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Recall Observatory FDA recall evidence

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

D-0226-2024

October 20, 2023

Class I

Product summary

Firm
Botanical Be
Event
Event 93257
Status
Ongoing
Classification
Class I
Quantity
300 bottles
Official record key
drug-enforcement:D-0226-2024

Official wording

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

Code information: All lots, exp 12/12/2024

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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