Pharmaceutical

FDA recalls potassium chloride injection due to labeling error

fda logo FDA recalls potassium chloride injection due to labeling errorBaxter International, Inc., is recalling one lot of potassium chloride injection because the drug packaging may contain units of gentamicin sulfate instead. Potassium chloride injection is used to treat potassium deficiency. Gentamicin sulfate is an antibacterial drug. This labeling error could result in a medication error or delay in therapy for patients who require high concentration of potassium chloride, the Food and Drug Administration (FDA) warned.

The recall involves Lot #P318220, NDC # 0338-079-48 of potassium chloride Injection 10mEq per 100mL, with the product code 2B0826. Shipping cartons labeled for this specific lot number of potassium chloride injection may contain units of gentamicin sulfate injection, 80mg in 100 mL, product code 2B0862.Both drug products are packaged in 100mL containers, have similar code numbers and red labeling the front panel.

The affected lot of potassium chloride injection was distributed to customers in the United States between May 26, 2014 and August 8, 2014. To date, there have been no reported adverse events associated with this labeling error.

Health care professionals have been alerted of the recall and advised what action to take. Medical staff and patients are advised to report any side effects or quality issues with this product to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA