FDA Removes Unapproved Cough, Cold and Allergy Products from Market

March 2, 2011

The FDA announced that it intends to remove certain unapproved prescription cough, cold, and allergy drug products from the U.S. market. 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). Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.

Review the list of the unapproved prescription cough, cold, and allergy drug products the FDA intends to remove from the market.

If you believe you are taking an unapproved prescription cough, cold, or allergy products, contact your health care provider to discuss alternatives.

For more information, please read the complete MedWatch Safety Alert.