Watch what you give your child to treat an ear infection, as the Food and Drug Administration is clamping down on unapproved prescription ear drops.
The agency wants companies to either get FDA approval for their unapproved ear drops or pull them from shelves, according to an announcement Wednesday. The enforcement action applies to 16 companies that create optic products labeled to relieve ear pain, infection and inflammation.
The unapproved ear drops contain active ingredients such as benzocaine and hydrocortisone but have not been evaluated by the FDA to be safe and effective, the agency said.
Other products contain antipyrine, zinc acetate, chloroxylenol and pramoxine.
The FDA is concerned the products could be manufactured incorrectly, which can lead to patients getting the wrong dose or be contaminated.
The agency said that if a consumer believes his or her prescription ear drop is affected to call their doctor. The agency did not disclose the names of the companies affected by the enforcement actions.
The enforcement push is part of a larger initiative by the FDA to take on unapproved consumer products.