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Recall Observatory FDA recall evidence

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

March 08, 2018

Class I

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

    reason.no_named_rule · v1.0.0

    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.