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FDA Intends to Remove Unapproved Drugs From Market

  • Date: 2011/03/02 (Rev: 2016/11/05) U.S. Food and Drug Administration
  • Synopsis : Regulators aim to take certain unapproved prescription medicines for cough cold and allergy symptoms off the U.S. market.

Main Document

Federal regulators aim to take certain unapproved prescription medicines intended to relieve cough, cold, and allergy symptoms off the U.S. market.

According to the U.S. FDA these products may be risky to use because they have not been evaluated by FDA to assure that they are safe, effective, and of good quality.

FDA announced Wednesday that the agency intends to remove certain unapproved prescription medicines intended to relieve cough, cold, and allergy symptoms from the U.S. market.

FDA officials say they have numerous concerns about these products: some may have potentially risky combinations of ingredients, while others marketed as "timed-release" may release active ingredients too slowly, too quickly, or inconsistently.

FDA has also received reports that some of the products have names that look or sound similar to other products a problem that could contribute to medication errors.

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register and list all of their commercially marketed drug products with the FDA.

Many drug firms do not update their drug listing information with FDA as required by law; consequently, the information in DRLS is both over- and under-inclusive.

To see a list of unapproved prescription cough, cold, and allergy products visit:

www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm

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