Recalls / Class I
Class ID-0646-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- All lots
Why it was recalled
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).
Recalling firm
- Firm
- Organic Herbal Supply
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8303 Sierra College Blvd Ste 128, N/A, Roseville, California 95661-9420
Distribution
- Quantity
- 100,000 to 150,000 capsules
- Distribution pattern
- Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
Timeline
- Recall initiated
- 2017-02-16
- FDA classified
- 2017-04-05
- Posted by FDA
- 2017-04-12
- Terminated
- 2017-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0646-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.