Baxter announced a voluntary recall of one lot of highly concentrated Potassium Chloride Injection 20mEq/50mL in a ViaFlex Container and three lots of 0.9% Sodium Chloride Injection due to particulate matter, found in the solutions. The particulate matter was identified as cellulosic fibers and/or plastics.
The injection of particulate matter may result in both chronic and acute inflammatory and allergic responses that may be life threatening. Sodium Chloride Injection is an injectable indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. Potassium Chloride Injection is an intravenously administered injectable indicated as a potassium replacement to support nerve conduction, muscle contraction and prevention of cardiac arrhythmias.
The affected products are packaged in 50mL and 100mL containers and were distributed between February 2013 and June 2014. The full list of recalled products can be found on the FDA website.
Baxter has notified customers not to use product from the recalled lots. Affected products should be returned to Baxter for credit by contacting (888) 229-0001.
For more information call (888) 229-0001 or visit the FDA Safety Alert page.