Baxter International Inc. is voluntarily recalling one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level, because of a complaint of mislabeling of the overpouch.
According to a press release on the FDA website, 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.
Products were distributed to U.S. customers between June 23, 2014 and Oct. 2, 2014. Unaffected lot numbers can continue to be used according to the instructions for use.
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.
