Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Slate Run Pharmaceuticals
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.