Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Product description
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
Lot numbers, UPCs & expiration codes
Lot #: 2107, Exp. Date 10/31/2024.
Where it was sold
Product distributed 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-0345-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Feb 6, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 5500 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Today The World
Original FDA data
Every field from FDA enforcement report D-0345-2024, exactly as published.
Show all FDA fields
- City
- Portland
- State
- OR
- Status
- Ongoing
- Country
- United States
- Event ID
- 93941
- Address
- 1954 NE Glisan St # 405
- Code information
- Lot #: 2107, Exp. Date 10/31/2024.
- Postal code
- 97220
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0345-2024
- Classification
- Class I
- Recalling firm
- Today The World
- Product quantity
- 5500 boxes
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
- Distribution pattern
- Product distributed nationwide within the United States.
- Recall initiation date
- Feb 6, 2024
- Initial firm notification
- Press Release
- Center classification date
- Feb 22, 2024