Why it was recalled
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Product description
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0024-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 8, 2024
- FDA report date
- Oct 30, 2024
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- C & A Naturistics
Original FDA data
Every field from FDA enforcement report D-0024-2025, exactly as published.
Show all FDA fields
- City
- National City
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 95520
- Address
- 2424 Hoover Ave Ste N
- Code information
- All Lots
- Postal code
- 91950-8575
- Report date
- Oct 30, 2024
- Product type
- Drugs
- Recall number
- D-0024-2025
- Classification
- Class II
- Recalling firm
- C & A Naturistics
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 8, 2024
- Initial firm notification
- Press Release
- Center classification date
- Oct 22, 2024