Summary
The FDA issued a Class II for AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, by C & A Naturistics. Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen..
Details
Source
Drug Recall
External ID
D-0024-2025
Action Date
2024-10-30
Status
Ongoing
Category
drug
Product Description
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Lot/Code Info: All Lots
Quantity Affected: Unknown
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-08
Company
National City, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 37 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (C & A Naturistics) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does C & A Naturistics have FDA actions?
This is the only FDA action we have on record for C & A Naturistics in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0024-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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