Products found to contain undeclared medicines
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| The United States: Celebrate Today issues voluntary nationwide recall of one lot of Red Mammoth due to the presence of undeclared sildenafil and tadalafil |
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The US Food and Drug Administration (FDA) announces that Celebrate Today is voluntarily recalling Red Mammoth capsules (lot number: DK1027) to the consumer level. Celebrate Today was informed by Amazon that laboratory analysis has found the product to be tainted with sildenafil and tadalafil, ingredients known as a phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in Red Mammoth 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 Red Mammoth capsules with undeclared sildenafil and 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, Celebrate Today has not received any reports of adverse events related to this recall.
Red Mammoth capsules are marketed as a dietary supplement for male enhancement.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/celebrate-today-issues-voluntary-nationwide-recall-one-lot-red-mammoth-due-presence-undeclared
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Feb 10, 2022
Issued at HKT 15:00
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