被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Fitoterapia USA Inc. issues voluntary nationwide recall of MERO MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT due to presence of active ingredient tadalafil (English only) |
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The US Food and Drug Administration (FDA) announces that Fitoterapia USA Inc., is voluntarily recalling 19,000 bottles of MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT, liquid dietary supplement to the consumer level. FDA analysis has found the product to be tainted with tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for the treatment of male erectile dysfunction. The presence of tadalafil in the product renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Consumers who take dietary supplements for erectile dysfunction could have underlying diseases such as diabetes, hypertension, or high cholesterol. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and phosphodiesterase 5- inhibitors can lead to fatal cardiovascular collapse. To date, Fitoterapia USA Inc. has not received any reports of adverse events related to this recall.
The affected product lots include the following, LOT: ZD-160-18 EXP: 09-07-2019, LOT: ZD-078-19 EXP: 27-04-2020, LOT: ZD-159-17 EXP: 31-05-2018. The product can be identified as a white bottle with a high print at the bottom (fitoterapia –logo), plastic label heated sealed, each bottle with its bar code. The product was distributed nationwide to retail stores and via internet since Apr 2019.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fitoterapia-usa-inc-issues-voluntary-nationwide-recall-mero-macho-artificial-passion-fruit-flavored
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 7 Sep 2019.
Ends/Tuesday, Sep 17, 2019
Issued at HKT 15:00
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