Product: AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Reason for recall: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Recall initiated: 20241008
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated