Drug & medication recalls Moderate risk

AK Forte Ortiga y Omega 3 Cont recalled over undeclared diclofenac

Recall date
October 8, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
C & A Naturistics recalls AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Recall number
D-0024-2025
FDA classification
Class II
Brand / firm
C & A Naturistics
Sold / distributed
Nationwide within the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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