D-0226-2024 Class I Ongoing
FDA drug recall D-0226-2024 was initiated by Botanical Be on October 20, 2023 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. The recall status is ongoing. Affected quantity: 300 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 6, 2023
- Initiation Date
- October 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 bottles
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.
Distribution Pattern
USA Nationwide
Code Information
All lots, exp 12/12/2024