The FDA is taking action against companies that manufacture and/or distribute certain unapproved prescription ear drop products, known as otic products, labeled to relieve ear pain, infection, and inflammation.
The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness, and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status.
In a federal register notice, the agency informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. The action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.
DA informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. Today’s action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.
