AK Forte Ortiga y Omega 3 Cont…

Date

Oct. 30, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

C & A Naturistics

Product

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

Reason

Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.

Distribution pattern

Nationwide within the United States

Quantity

Unknown

Codes and lots

All Lots

Recall started

Oct. 8, 2024

Recall number

D-0024-2025

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0024-2025. The agency record governs; check it and the company before acting.