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Business · 02/07/2015Updated: 10/17/2026 · 1 min read

FDA Announces Enforcement Action Against Misbranded Otic Prescription Drug Products Containing Benzocaine

Summary

The FDA is taking enforcement action against unapproved and misbranded otic prescription drug products containing benzocaine, which are marketed without evidence of safety and effectiveness, posing safety concerns and challenging the new drug approval system.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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