November 2019 FDA Recall Drug by Natures Rx
D-0633-2020 - Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.

This Class I drug recall was voluntarily initiated by Natures Rx on November 13, 2019 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product contains undeclared active ingredient - sildenafil.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0633-2020

Reason for Recall
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Initiated
11-13-2019
Reported
01-08-2020
Quantity
2,800 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84279
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2023
Product Description About Product Description
Full technical description of the product.
Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.

Batch or Lot Expiration Information

Lot# 01251ZX1, exp. date 11/2022 UPC: 610877392698