Home / Recalls / Organic Herbal Supply / D-0646-2017

D-0646-2017 Class I Terminated

Recalled by Organic Herbal Supply — Roseville, CA

Recall Details

Product Type
Drugs
Report Date
April 12, 2017
Initiation Date
February 16, 2017
Termination Date
September 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100,000 to 150,000 capsules

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

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 Pattern

Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com

Code Information

All lots

Other recalls by Organic Herbal Supply

  • D-0965-2017 Class I — RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied i (April 18, 2017)
  • D-0964-2017 Class I — Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, (April 18, 2017)
  • D-0966-2017 Class I — TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, (April 18, 2017)
  • D-0961-2017 Class I — UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied (April 18, 2017)
  • D-0971-2017 Class I — LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packa (April 18, 2017)
  • D-0963-2017 Class I — ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2 (April 18, 2017)
  • D-0970-2017 Class I — ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count (April 18, 2017)
  • D-0968-2017 Class I — BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied (April 18, 2017)
  • D-0962-2017 Class I — Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, sup (April 18, 2017)
  • D-0969-2017 Class I — ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 (April 18, 2017)