January 2019 FDA Recall Drug by Natures Rx
D-0500-2019 - Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

This Class I drug recall was voluntarily initiated by Natures Rx on January 25, 2019 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; fda analysis found product to be tainted with undeclared sildenafil and tadalafil. The product was distributed in eBay sales and the recall is currently terminated.

Recall Number: D-0500-2019

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Initiated
01-25-2019
Reported
02-13-2019
Quantity
211

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81999
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.
Natures Rx
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.
eBay sales
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-06-2023
Product Description About Product Description
Full technical description of the product.
the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA

Batch or Lot Expiration Information

Lot# All lots within expiry