Why it was recalled
Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Product description
Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
Lot numbers, UPCs & expiration codes
UPC # 891656002209, exp date 12/31/2021
Where it was sold
Product was distributed online via eBay.
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-0625-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 8, 2018
- FDA report date
- Apr 4, 2018
- Quantity
- 315 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jimmy Weber
Original FDA data
Every field from FDA enforcement report D-0625-2018, exactly as published.
Show all FDA fields
- City
- Los Angeles
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79476
- Address
- 450 N Van Ness Ave Apt 107
- Code information
- UPC # 891656002209, exp date 12/31/2021
- Postal code
- 90004-1577
- Report date
- Apr 4, 2018
- Product type
- Drugs
- Recall number
- D-0625-2018
- Classification
- Class I
- Recalling firm
- Jimmy Weber
- Product quantity
- 315 capsules
- Termination date
- Jul 26, 2019
- Reason for recall
- Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
- Distribution pattern
- Product was distributed online via eBay.
- Recall initiation date
- Mar 8, 2018
- Initial firm notification
- Center classification date
- Apr 11, 2018