FDA Sounds Off On Unapproved Ear Drops Through Enforcement Notice
This article was originally published in The Tan Sheet
Executive Summary
FDA says firms marketing unapproved and misbranded prescription otic products containing one or more of antipyrine, benzocaine, chloroxylenol, hydrocortisone, pramoxine and zinc acetate will be subject to enforcement actions including seizure, injunction and/or criminal proceedings.