February 2017 FDA Recall Drug by Organic Herbal Supply
D-0646-2017 - Marketed without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Organic Herbal Supply on February 16, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0646-2017

Reason for Recall
Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
Initiated
02-16-2017
Reported
04-12-2017
Quantity
100,000 to 150,000 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76511
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.
Organic Herbal Supply
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-13-2017
Product Description About Product Description
Full technical description of the product.
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768

Batch or Lot Expiration Information

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