被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: HIS issues voluntary nationwide recall of Miss Slim due to the presence of undeclared sibutramine (English only) |
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The US Food and Drug Administration (FDA) announces that HIS is voluntarily recalling all lots and all presentations of Miss Slim (10 count and 30 count capsules) to the consumer level. HIS decided to recall Miss Slim after it was contacted by the FDA regarding the presence of sibutramine in the product.
Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues.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 Miss Slim renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. To date, HIS has not received any reports of adverse events related to this recall.
Products containing sibutramine pose a threat 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 a 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/his-issues-voluntary-nationwide-recall-miss-slim-due-presence-undeclared-sibutramine
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 Jun 2021.
Ends/Friday, Jul 23, 2021
Issued at HKT 16:00
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