Products found to contain undeclared medicines
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| The United States: Volt Candy issues voluntary nationwide recall of PrimeZen Black 6000 capsules due to presence of sildenafil and tadalafil |
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The US Food and Drug Administration (FDA) announces that Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000 (2000 mg capsule) (lot number: NPINPB1003) to the consumer level. FDA analysis has found PrimeZen Black 6000 capsules to be tainted with sildenafil and tadalafil.
Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in PrimeZen Black 6000 capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/volt-candy-issues-voluntary-nationwide-recall-primezen-black-6000-capsules-due-presence-sildenafil
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 8 Feb 2023.
Ends/Wednesday, Feb 15, 2023
Issued at HKT 15:00
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