Drug product
Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
D-0225-2024
Product summary
- Firm
- Botanical Be
- Event
- Event 93257
- Status
- Ongoing
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0225-2024
Official wording
Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Code information: All lots, exp 10/20/2024
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.