USALESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey.
Brooklyn, NY, March 22, 2019 --(PR.com)-- USALESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil
USA LESS is voluntarily recalling LEOPARD Miracle Honey to the consumer level. FDA analysis has found LEOPARD Miracle Honey to be tainted with sildenafil. Sildenafil is an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in LEOPARD Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; consumption of undeclared sildenafil along with nitrates could result in a drop in blood pressure that is life-threatening and could result in serious adverse health consequences. To date, USA LESS has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement for men for sexual enhancement and is packaged in a wooden box labeled as LEOPARD Miracle Honey, containing 12 sachets, total 180 Gr/6.36 oz. Also, 1 sachet 15 gr/0.53 oz, labeled LEOPARD Miracle of Honey. Product was distributed nationwide in the USA to distributors and consumers.
USA LESS is notifying its distributors and customers & consumers thru e-mail, and is arranging for returns of all recalled products purchased from USA LESS. Consumers/distributors/retailers that have purchased this recalled product from usa less should stop using/return to: USA LESS, PO Box 250-138 Brooklyn, NY 11225.
Any questions contact us regarding this recall by phone at 800-872-5377 Monday through Friday, from 9AM-5PM EST, or by e-mail at USALESS@optonline.net.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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Read the full story here: https://www.pr.com/press-release/780531
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|Publication:||PR.com (Press Releases)|
|Date:||Mar 22, 2019|
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