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Recall Observatory FDA recall evidence

Drug 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

D-0646-2017

February 16, 2017

Class I

Product summary

Firm
Organic Herbal Supply
Event
Event 76511
Status
Terminated
Classification
Class I
Quantity
100,000 to 150,000 capsules
Official record key
drug-enforcement:D-0646-2017

Official wording

Reason: 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).

Code information: All lots

Distribution pattern: Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).