Drug Enforcement D-0024-2025

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

Status

Ongoing

Classification

Class II

Report Date

October 30, 2024

Termination Date

—

Product Information

Product description
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Product quantity
Unknown
Reason for recall
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
C & A Naturistics
Address
2424 Hoover Ave Ste N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0024-2025
Event ID
95520
Recall initiation date
October 8, 2024
Center classification date
October 22, 2024
Code info
All Lots
More code info
—