被 发 现 含 有 未 标 示 西 药 的 产 品
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The United States: Junp LLC issues voluntary nationwide recall of MegMan Performance Booster Capsules due to the presence of tadalafil (English only) |
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The US Food and Drug Administration (FDA) announces that Junp LLC is voluntarily recalling one lot of MegMan Performance Booster Capsules (Lot number 2010291) to the consumer level. Junp LLC was notified by Amazon that laboratory analysis has found the product to be tainted with Tadalafil. Tadalafil is an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in MegMan Performance Booster makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.
Consumers with underlying medical issues who take MegMan Performance Booster Capsules with undeclared 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, Junp LLC has not received any reports of adverse events related to this recall.
MegMan Performance Booster Capsules are marketed as a dietary supplement for male sexual enhancement.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/junp-llc-issues-voluntary-nationwide-recall-megman-performance-booster-capsules-due-presence
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Saturday, Feb 5, 2022
Issued at HKT 12:00
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