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FDA Prompts Removal of Unapproved Drugs From Market
Date:3/2/2011

ed prescription product is an unnecessary risk.  

Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.  

This is the 17th action on a drug class as part of FDA's Unapproved Drugs Initiative, which began in June 2006.  The initiative is the agency's risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process.  One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality.  

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of unapproved prescription cough, cold, and allergy products to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.


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SOURCE U.S. Food and Drug Administration
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