Posted from: Tuesday, August 04, 2015 - 12:14 PM - Present

The U.S. Food and Drug Administration Addresses Unapproved Prescription Ear Drop Products

The U.S. Food and Drug Administration notified manufacturers asking them to stop manufacturing unapproved prescription ear (otic) drugs, otherwise strict repercussions including seizure, injunction, and or criminal proceedings may be enforced. Although these products have not been evaluated by the FDA for safety, effectiveness and quality, they are indicated to treat otitis media (middle ear infections), swimmer’s ear, and other ear conditions. They contain active ingredients like benzocaine and hydrocortisones, which help to manage inflammation and pain. With approval of these otic products still pending, the FDA noted that several OTC and approved prescription options are currently available for said conditions.


Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

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*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Saturday, October 19, 2019 - 11:28 PM.