Products found to contain undeclared medicines
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| The United States: D.B.P. Distribution issues voluntary nationwide recall of Titanium 4000 due to presence of undeclared sildenafil and tadalafil |
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The US Food and Drug Administration (FDA) announces that D.B.P. Distribution is voluntarily recalling all lots of Titanium 4000 capsules to the consumer level. FDA analysis has found this product to be tainted with sildenafil and tadalafil. Sildenafil and tadalafil are both FDA approved active ingredients used for the treatment of erectile dysfunction and are in a class of drugs called phosphodiesterase (PDE-5) inhibitors. The presence of sildenafil and tadalafil makes Titanium 4000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. To date, D.B.P. Distribution has not received any reports of adverse events related to this recall.
Consumers who take Titanium 4000 with undeclared sildenafil and that have underlying conditions such as diabetes, hypertension or high cholesterol often take nitrates. Concomitant use of nitrates and PDE-5 inhibitors can lower blood pressure to dangerous levels which can be life threatening. Titanium 4000 is used as a male enhancement nutritional supplement and is packaged in 30 count display boxes, with single pill packs containing a red and black pill. Titanium 4000 was distributed nationwide to users via the internet and from www.discountbonerpills.com.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dbp-distribution-issues-voluntary-nationwide-recall-titanium-4000-due-presence-undeclared-sildenafil
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, May 8, 2019
Issued at HKT 15:00
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