Products found to contain undeclared medicines
|
| |
| The United States: Esupplementsales, LLC issues a nationwide recall of one lot of Hard Dawn due to the presence of undeclared tadalafil |
| |
The US Food and Drug Administration (FDA) announces that Esupplementsales, LLC is voluntarily recalling lot number 2107 of Hard Dawn Rise and Shine capsules to the consumer level. Esupplementsales, LLC was informed by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Hard Dawn Rise and Shine capsules renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Consumers with underlying medical conditions who take Hard Dawn Rise and Shine capsules with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Esupplementsales, LLC has not received any reports of adverse events related to this recall.
Hard Dawn Rise and Shine capsules are marketed as a dietary supplement for male sexual enhancement.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/esupplementsales-llc-issues-nationwide-recall-one-lot-hard-dawn-due-presence-undeclared-tadalafil
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Feb 4, 2022
Issued at HKT 16:00
|
| |
