FDA-Drug2017-04-12Class I

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

Organic Herbal Supply
Hazard

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).

Sold states
Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
Affected count
100,000 to 150,000 capsules
Manufactured in
8303 Sierra College Blvd Ste 128, N/A, Roseville, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2017

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