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).
Product description
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
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0646-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 16, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- 100,000 to 150,000 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Organic Herbal Supply
Original FDA data
Every field from FDA enforcement report D-0646-2017, exactly as published.
Show all FDA fields
- City
- Roseville
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 76511
- Address
- 8303 Sierra College Blvd Ste 128
- Code information
- All lots
- Postal code
- 95661-9420
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0646-2017
- Classification
- Class I
- Recalling firm
- Organic Herbal Supply
- Product quantity
- 100,000 to 150,000 capsules
- Termination date
- Sep 13, 2017
- 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
- Recall initiation date
- Feb 16, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2017