Class I
Terminated
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
This recall has been terminated (originally issued April 12, 2017).
- Company
- Organic Herbal Supply
- Recall Initiated
- February 16, 2017
- Posted
- April 12, 2017
- Recall Number
- D-0646-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 100,000 to 150,000 capsules
- Firm Location
- Roseville, CA, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
All lots
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