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U.S. Marshals, at the request of the U.S. Food and Drug Administration, yesterday seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky. Auralgan is manufactured for Deston Therapeutics, located in Chapel Hill, N.C., and is warehoused at ICS.
On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, citing the company for distributing unapproved new drugs and misbranded drugs. The FDA also warned Deston that Auralgan was an unapproved new drug in April, June, and September 2010, and the company continued distributing the drug in violation of the Federal Food, Drug, and Cosmetic Act. Today's action is part of the FDA's Unapproved Drugs Initiative, established in 2006 to get unapproved drugs either approved or off the market.
Originally posted by ~Lucidity
I understood that part. But their reason was still that it was not FDA approved. And if you're right, and there are five more pumping it out tomorrow, that's even worse.