Baxter International Inc. announced it is voluntarily recalling one lot of potassium chloride injection 10mEq per 100mL, product code 2B0826 to the hospital/pharmacy/nurse level. The recall is being initiated due to a labelling error on the shipping cartons in a single lot, which was identified by three customers. Shipping cartons labelled 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 labelling 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.

As part of standard clinical practice, it is recommended that healthcare professionals carefully review the product label before administering. There have been no reported adverse events associated with this situation to date.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting programme either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the US Food and Drug Administration (US FDA).

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions.