Mislabeling Leads to Recall of Highly Concentrated Potassium Chloride
Baxter announced a voluntary recall of one lot of Highly Concentrated Potassium Chloride Injection 10mEq/100mL at the user level. This recall is due to a complaint of mislabeling of the overpouch.
The affected product has Lot #P319160, NDC 0338-0709-48, Product Code 2B0826, with an expiration date of 6/30/2015. The Highly Concentrated Potassium Chloride Injection 10mEq/100mL was incorrectly labeled on the overpouch as Highly Concentrated Potassium Chloride Injection 20mEq/100mL.
The overpouch labeling error if not detected at the point of care may result in the administration of a dose lower than intended. In the high-risk patient population such as those patients prone to severe electrolyte imbalance, this may lead to serious, life-threatening adverse health consequences. The affected lot was distributed between June 23, 2014 and October 2, 2014.
Potassium Chloride Injection is indicated for intravenous (IV) treatment of potassium deficiency.
For more information call (800) 422-9837 or visit FDA.gov.