FDA recall D-0024-2025

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.

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-10-08

Report date

2024-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

National City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0024-2025