March 2018 FDA Recall Drug by Jimmy Weber
D-0625-2018 - 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.

This Class I drug recall was voluntarily initiated by Jimmy Weber on March 8, 2018 for the product Drug. The FDA reported the reason for recall as 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.. The product was distributed in Product was distributed online via eBay. and the recall is currently terminated.

Recall Number: D-0625-2018

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.
Initiated
03-08-2018
Reported
04-04-2018
Quantity
315 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79476
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jimmy Weber
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed online via eBay.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-26-2019
Product Description About Product Description
Full technical description of the product.
Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021

Batch or Lot Expiration Information

Lot# UPC # 891656002209, exp date 12/31/2021