被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine (English only) |
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The United States Food and Drug Administration (FDA) announces that eBay Seller ID: jongu 4308 of Houston, Texas, is voluntarily recalling all lots of Hydro Pineapple Burn to consumer level. FDA analysis has found the product to contain undeclared sibutramine. Sibutramine was an FDA approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues. The presence of sibutramine in Hydro Pineapple Burn renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to recall. As of August 11, 2021, jongu 4308 has not receive any report of adverse events related to this recall.
Products containing sibutramine pose a health risk to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Please refer to the following website in FDA for details:http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jongu-4308-issues-voluntary-nationwide-recall-hydro-pineapple-burn-due-presence-undeclared
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the FDA, and was posted on the Drug Office website on 18 Dec 2020.
Ends/ Thursday, August 12, 2021
Issued at HKT 12:30
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