Acting on behalf of the FDA, U.S. Marshals Tuesday confiscated all lots of Auralgan Otic Solution, a prescription ear-infection treatment manufactured by Deston Therapeutics, on the grounds that the medication is an unapproved drug. In addition to violating the Federal Food, Drug, and Cosmetic Act, the labeling for the drug does not contain adequate directions for use, the agency says. The seized product, worth an estimated $16.5 million according to the FDA, was taken from an Integrated Commercialization Solutions (ICS) warehouse in Books, Ky. ICS, a third-party logistics provider, declined to comment on the seizure.
Washington Drug Letter