FDA Recall D-0646-2017
Organic Herbal Supply · Roseville, CA
Class I — life-threatening Terminated 209 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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).
Recall record
- Recall number
D-0646-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
- Recall initiated
- 2017-02-16
- Classified by FDA Center
- 2017-04-05
- FDA published
- 2017-04-12
- Terminated
- 2017-09-13
- Recalling firm
- Organic Herbal Supply
- Firm location
- Roseville, CA