September 2017 FDA Recall Drug by Natures Supplement
D-0149-2018 - Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.

This Class I drug recall was voluntarily initiated by Natures Supplement on September 20, 2017 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 sildenafil.. The product was distributed in Florida and the recall is currently terminated.

Recall Number: D-0149-2018

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
Initiated
09-20-2017
Reported
01-10-2018
Quantity
308 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78073
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 Supplement
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.
Florida
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-01-2019
Product Description About Product Description
Full technical description of the product.
Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA --- UPC# 8931028556885

Batch or Lot Expiration Information

Lot# All lots, Exp. 02/23/2020