Products found to contain undeclared medicines
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| The United States: USA LESS issues voluntary nationwide recall of LEOPARD Miracle Honey due to presence of undeclared sildenafil |
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The US Food and Drug Administration (FDA) announces that USA LESS is voluntarily recalling all lots of 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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm634314.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 15 Mar 2018.
Ends/Tuesday, Mar 26, 2019
Issued at HKT 16:00
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