FDA recall: sodium bicarbonate in 5% dextrose injection by SterRx

SterRx is recalling three lots of sodium bicarbonate in 5% dextrose injection 150 mEq per 1,000 mL due to waterborne microbial contamination.

Intravenous administration of sodium bicarbonate in 5% dextrose injection 150 mEq per 1,000 mL, intended to be sterile that is not sterile, could result in site specific infections as well as serious systemic infections,  which may be life-threatening. To date, SterRx has not received reports of any adverse events associated with this issue.

Sodium bicarbonate injection is indicated for the following conditions:

• High Potassium (Hyperkalemia)
• Irregular heartbeat (QRS prolongation ex. tricyclic antidepressant poisoning)
• Metabolic acidosis related to severe renal disease, uncontrolled diabetes, severe primary lactic acidosis, circulatory insufficiency due to shock, severe dehydration, extracorporeal circulation of blood, cardiac arrest, drug toxicities, barbiturates, salicylate, toxic alcohols, urine alkalization, severe diarrhea with HCO3 loss.

FDA Recall