Unapproved Cough, Cold, Allergy Products intended to be Removed by the FDA

The FDA announced its intention to remove certain unapproved prescription cough, cold, and allergy drug products from the U.S. market because they have not been evaluated for their safety and quality and people may be at greater risk than with approved drugs.

Background of Unapproved Cough, Cold, Allergy Products

Cough, cold, and allergy drug products are used for the relief from symptoms related to the common cold or upper respiratory allergies.

FDA Alert on Unapproved Cough, Cold, Allergy Products

FDA’s reason for the removal is that there are unapproved cough, cold and allergy products that have not been evaluated by the FDA for their safety and quality. Therefore people may be at greater risk compared to products approved by the FDA.  These unapproved products do not mention in their label that they lack FDA approval.

Recommendation on Unapproved Cough, Cold, Allergy Products

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

Contacting the FDA to report cases with Unapproved Cough, Cold, Allergy Products

In case of detection of adverse events or side effects related to the use of Unapproved Cough, Cold, Allergy Products, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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