AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

FDA Recall #D-0024-2025 — Class II — October 8, 2024

Recall #D-0024-2025 Date: October 8, 2024 Classification: Class II Status: Ongoing

Product Description

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.

Recalling Firm

C & A Naturistics — National City, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

Unknown

Distribution

Nationwide within the United States

Code Information

All Lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated