Determination That PLASMA-LYTE M AND DEXTROSE 5% and PLASMA LYTE 148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 milligrams (mg)/100 milliliters (mL); dextrose, 5 grams (g)/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium gluconate, 502 mg/100 mL) were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.