D-0024-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- October 30, 2024
- Initiation Date
- October 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
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 Pattern
Nationwide within the United States
Code Information
All Lots