Unapproved prescription and generic ear drops taken off the market
November 18, 2015
The US Food & Drug Administration (FDA) has taken all forms of unapproved prescription ear drop products (known at otic products) labeled to relieve ear pain, infection and inflammation, off the market. The products will no longer be available in any pharmacies or other retail locations.
The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not yet been evaluated by the FDA for safety, effectiveness and quality. Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling.
Following the FDA's recommendation, ARC no longer prescribes ear drops containing the unapproved contents. If you have prescription ear drops with benzocaine and hydrocortisone and are concerned, please call your ARC physician's office.
The FDA's official press release announcement can be found online here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453348.htm
For more information, visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm453087.htm