新 聞 及 資 訊
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The United States: U.S. Marshals seize Auralgan Otic Solution(English Only) |
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U.S. Marshals, at the request of the U.S. Food and Drug Administration, seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky. Auralgan is manufactured for Deston Therapeutics, located in Chapel Hill, N.C., and is warehoused at ICS. Deston’s sale of the product in the United States violates federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm243638.htm
In Hong Kong, there is no record of registration for the above product.
Ends/ Thursday, February 17, 2011
Issued at HKT 15:30
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