2." NXTR said that it uncovered this material, produced by a single sales representative, before receiving the FDA's letter and that the individual was discharged and the material withdrawn. In compliance with the letter, the company also has contacted its other sales representatives and instructed them to stop disseminating the materials mentioned in the FDA letter.

In addition, the FDA charged that the company distributed materials claiming that DaunoXome has shown a reduced risk of cardiotoxicity, which the agency argued is unsubstantiated.