Determination That Bacitracin for Injection, 10,000 Units/Vial and 50,000 Units/Vial, Was Withdrawn From Sale for Reasons of Safety or Effectiveness

الملخص

The Food and Drug Administration (FDA or Agency) has determined that bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for bacitracin for injection.