Intravenous Antibacterial Drug Mislabeled as Injectable Potassium Chloride

Baxter International Inc. recalled one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 to the hospital/pharmacy/nurse level due to a labeling error on the shipping cartons in a single lot, which was identified by three customers.


Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, 80 mg in 100 mL, product code 2B0862.


Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Gentamicin Sulfate is an antibacterial drug for intravenous administration. As both products are packaged in 100mL containers, have similar code numbers, and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.


The affected lot of Potassium Chloride Injection was distributed to customers in the United States between May 26, 2014, and August 8, 2014. This recall affects the lot number P318220 of Potassium Chloride Injection 10mEq per 100mL. The affected lot bears the NDC number 0338-0709-48.


See the Recall


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication