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The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.
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 (i.e., 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, reported the company in a press release.
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 June 23, 2014 and Oct. 2, 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. The recall is being conducted with the knowledge of FDA.