Drug Enforcement D-0226-2024

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

Status

Ongoing

Classification

Class I

Report Date

December 6, 2023

Termination Date

—

Product Information

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
Product quantity
300 bottles
Reason for recall
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Botanical Be
Address
360 Jardin Bello

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0226-2024
Event ID
93257
Recall initiation date
October 20, 2023
Center classification date
January 12, 2024
Code info
All lots, exp 12/12/2024
More code info
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