被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Meta Herbal issues voluntary nationwide recall of Magnum XXL 9800 capsules due to presence of undeclared sildenafil (English only) |
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The US Food and Drug Administration (FDA) announces that Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 (2000 mg per capsule) to the consumer level. The product has been found to be tainted with sildenafil.
Sildenafil is an ingredient known as a phosphodiesterase inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction. Products containing sildenafil cannot be marketed as dietary supplements. Magnum XXL 9800 capsules is an unapproved new drug for which safety and efficacy has not been established and, therefore, subject to recall.
Consumption of products with undeclared sildenafil 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 this product, adult males who use nitrates for cardiac conditions are most at risk. To date, Meta Herbal has not received any reports of adverse events related to this recall.
The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister packs of one pill.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meta-herbal-issues-voluntary-nationwide-recall-magnum-xxl-9800-capsules-due-presence-undeclared
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 25 Nov 2020 and 9 Dec 2021.
Ends/Thursday, Nov 30, 2023
Issued at HKT 14:30
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