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The United States: FDA prompts removal of unapproved drugs from market(English Only)
 
The U.S. Food and Drug Administration took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States. Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC). Companies that have previously listed products subject to this action with FDA are expected to stop manufacturing them within 90 days and stop shipping the products within 180 days. Companies that have not previously listed products subject to this action with FDA are expected to stop manufacturing and shipping their products immediately.

Please refer to the following website in FDA for details: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245048.htm

According to the name of drug listed by FDA, one product, namely Deconamine SR Cap (HK-41507), is registered in Hong Kong by a local company called The International Medical Co. Ltd.. The company confirmed that the product was discontinued about 2 years ago and it is no longer marketed in Hong Kong.



Ends/ Thursday, March 3, 2011
Issued at HKT 15:30


 
 
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