Drug product
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
D-0024-2025
Product summary
- Event
- Event 95520
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0024-2025
Official wording
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Code information: All Lots
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.