FDAFDA · Food and drugs·Recall number D-0646-2017
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
Published April 12, 2017 · Recall initiated: February 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Organic Herbal Supply
- Distributor
- Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
- Lot
- All lots
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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