被 发 现 含 有 未 标 示 西 药 的 产 品
|
| |
| The United States: Proper Trade LLC/My Stellar Lifestyle issues voluntary nationwide recall of Wonder Pill due to the presence of undeclared tadalafil (English only) |
| |
The US Food and Drug Administration (FDA) announces that Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill (lot 20210912 and lot 31853-501) to the consumer level. Proper Trade LLC/My Stellar Lifestyle was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil, 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 Wonder Pill 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 the Wonder Pill 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, Proper Trade LLC/ My Stellar Lifestyle has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters co-packaged in a carton and packaged in a 60-count bottle.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/proper-trade-llcmy-stellar-lifestyle-issues-voluntary-nationwide-recall-wonder-pill-capsules-due
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Sep 29, 2022
Issued at HKT 15:00
|
| |
