Drug product
Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
D-0625-2018
Product summary
- Firm
- Jimmy Weber
- Event
- Event 79476
- Status
- Terminated
- Classification
- Class I
- Quantity
- 315 capsules
- Official record key
drug-enforcement:D-0625-2018
Official wording
Reason: 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.
Code information: UPC # 891656002209, exp date 12/31/2021
Distribution pattern: Product was distributed online via eBay.
Derived failure modes
-
Unknown
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.