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February 17, 2011

U.S. Marshals Seize Auralgan Otic Solution (Unapproved FDA Medication)

Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, was being distributed in violation of federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.

On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, the maker of Auralgan, citing the company for distributing unapproved new drugs and misbranded drugs.

As such, on Feb 15, 2011, US Marshals seized all lots of Auralgan Otic Solution warehoused at Integrated Commercialization Solutions Inc. (ICS) in Brooks, KY.

Read the FDA notice here.

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Fauquier blog
Fauquier ENT

Dr. Christopher Chang is a private practice otolaryngology, head & neck surgeon specializing in the treatment of problems related to the ear, nose, and throat. Located in Warrenton, VA about 45 minutes west of Washington DC, he also provides inhalant allergy testing/treatment, hearing tests, and dispenses hearing aids.

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