NEW HANOVER COUNTY, NC (WECT) - The FDA announced it intends to remove certain unapproved prescription medicines intended to relieve cough, cold, and allergy symptoms off store shelves.
The following is from the FDA's website:
These products have not been evaluated by FDA to assure that they are safe, effective, and of good quality. These products may therefore pose unnecessary risk to consumers, especially when there are other products available for treatment of cough, cold, and allergy symptoms, including FDA-approved prescription drugs or over-the-counter drugs that follow appropriate FDA standards.
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.
In addition, FDA health experts are concerned that some of the products are inappropriately labeled for use by infants and young children. Many of the unapproved drug products covered by today's announcement contain the same ingredients as the over-the-counter cough and cold products that were the subject of a 2008 FDA public health advisory.