被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Golean Detox USA issues voluntary nationwide recall of Golean DETOX Capsules due to presence of undeclared sibutramine and phenolphthalein (English Only) |
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The US Food and Drug Administration (FDA) announces that Golean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in Golean DETOX renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to 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. Health risks of ingesting phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, Golean Detox USA has not received any reports of adverse events related to this recall.
This tainted product is marketed as a dietary supplement for weight loss and is packaged in 14 packets containing 2 capsules per packet, a total of 28 capsules per box. Golean DETOX capsules were sold nationwide in the US to customers on Facebook at www.goleandetoxus.com.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm632004.htm
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 29 Jan 2019.
Ends/Tuesday, Feb 26, 2019
Issued at HKT 17:00
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