Products found to contain undeclared medicines
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| The United States: Male enhancement supplements recalled |
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The US Food and Drug Administration (FDA) announces that Integrity Products is voluntarily recalling tainted lot (HGW221116) within expiry of the Ram It and To The Moon capsules to the consumer level. FDA analysis found the products to be tainted with sildenafil and tadalafil. Sildenafil or tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Ram It and To The Moon products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. To date, Integrity Products has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/male-enhancement-supplements-recalled
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 27 Dec 2023.
Ends/Wednesday, Jun 12, 2024
Issued at HKT 15:45
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