FDA Takes Action Against Companies Making Unapproved Rx Ear Drops

The FDA July 2 said it is taking enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products labeled to relieve ear pain, infection and inflammation.

The unapproved prescription ear drops, known as otic products, contain active ingredients such as benzocaine and hydrocortisone, and haven’t been evaluated by the Food and Drug Administration for safety, effectiveness and quality, the agency said in a Federal Register notice published July 2 (80 Fed. Reg. 38,212).

The labels on these products don’t disclose that they lack FDA approval, and health-care professionals may not be aware of ...