FDA Takes Action Against unapproved Prescription Ear Drop Products

FDA has announced its intention to take enforcement 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. This action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.

Unapproved prescription otic drug products containing the following ingredients are covered by this action:

• benzocaine;
• benzocaine and antipyrine;
• benzocaine, antipyrine, and zinc acetate;
• benzocaine, chloroxylenol, and hydrocortisone;
• chloroxylenol and pramoxine; and
• chloroxylenol, pramoxine, and hydrocortisone.

Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.