FDA Orders Halt to Unapproved Prescription Ear Drops

Miriam E. Tucker


July 01, 2015

The US Food and Drug Administration (FDA) has demanded a halt to the manufacture and distribution of unapproved prescription ear drop products labeled to relieve ear pain, infection, and inflammation.

The products, which contain active ingredients such as benzocaine and hydrocortisone, have not been evaluated by the FDA for safety, effectiveness, or quality. Without such assurance, the products could be contaminated and/or manufactured incorrectly, possibly resulting in patients receiving the wrong dose even when following the label directions, the FDA said in a statement.

For a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the US without required FDA approval. None of the otic products in this action are approved under current law. Many healthcare professionals are likely unaware of the unapproved status of these drug products and have unknowingly prescribed them because the drugs' labels do not disclose that they lack FDA approval, an FDA spokesperson told Medscape Medical News.

In a Federal Register notice published July 1, 2015, the FDA warned the manufacturers of these products that they must halt their production and shipping immediately or be subjected to enforcement actions, including seizure, injunction, and/or criminal proceedings.

The products covered by the action contain the following ingredients:

• benzocaine;

• benzocaine and antipyrine;

• benzocaine, antipyrine, and zinc acetate;

• benzocaine, chloroxylenol, and hydrocortisone;

• chloroxylenol and pramoxine; and

• chloroxylenol, pramoxine, and hydrocortisone.

This action does not apply to FDA-approved prescription otic products or legally marketed otic products sold over the counter.

"Taking enforcement actions against these unapproved products will protect patients from unnecessary risks," said Cynthia Schnedar, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "There are many FDA-approved prescription products to treat ear infections, so we expect little or no impact on patients from the removal of these unapproved and potentially unsafe products."


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