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Titration involves starting at a very low dose and gradually increasing it over several months

The FDA describes a facility where drug products intended to be sterile were produced in environments that may not have provided adequate contamination protection, where products that failed sterility and potency testing were released and distributed, where out-of-specification investigation procedures were not followed in a single documented case out of 23 reviewed, and where patients were not notified when the drugs they received were found to be subpotent or failed sterility testing

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In some embodiments, the otic formulation or composition comprises about 25% by weight of the cholesterol