FDA Recall D-0024-2025
C & A Naturistics · National City, CA
Class II Ongoing 583 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Recall record
- Recall number
D-0024-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-10-08
- Classified by FDA Center
- 2024-10-22
- FDA published
- 2024-10-30
- Recalling firm
- C & A Naturistics
- Firm location
- National City, CA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.