Baxter Initiates Voluntary Recall of One Lot of Highly Concentrated Potassium Chloride Injection in the US

Baxter International is voluntarily recalling one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level due to a complaint of mislabeling of the overpouch. The inability to detect this overpouch mislabeling at the point of care may result in the administration of a dose lower than intended. In the
high-risk patient population — patients prone to severe electrolyte imbalance — this hazardous situation may lead to serious, life-threatening adverse health consequences. There have been no reported adverse events associated with this issue to date.

Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Some containers of Product Code 2B0826, Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL, Lot Number P319160, Exp. 06/30/2015, NDC 0338-0709-48 were incorrectly labeled on the overpouch as Highly Concentrated Potassium Chloride Injection, 20 mEq per 100 mL. Products were distributed to customers in the US between 23 June 2014 and 2 October 2014. Unaffected lot numbers can continue to be used according to the instructions for use.

Baxter has notified customers, who are being directed not to use product from the recalled lot.