FDA recall D-0646-2017

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

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).

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-02-16

Report date

2017-04-12

Termination date

2017-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Roseville, CA, United States

Primary source

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