Baxter Voluntarily Recalls Four Lots of IV Solution Due to Particulate Matter
Baxter International Inc. is voluntarily recalling four lots of intravenous solutions to the hospital/user level. These products have been found to contain particulate matter identified as cellulosic fibers and/or plastics. Baxter received four complaints over a period of six months from customers whose visual inspection identified the appearance of visible particulate matter prior to administration to a patient.
The recall applies to three lots of sodium chloride solution and one lot of potassium chloride solution. The affected lots are: 0.9% sodium chloride 100 mL (Quad Pack) (Lot # P298190, expiration date August 2014); 0.9% sodium chloride 100 mL Mini Bag Plus (Lot # P308650), expiration date October 2014; 0.9% sodium chloride, 50-mL (Single Pack) (Lot # P309187, expiration date October 2014); and highly concentrated potassium chloride injection, 20 mEq/50 mL, Viaflex Plus Container (Lot # P309476, expiration date October 2014).
The lots being recalled were distributed worldwide to customers and distributors between February 2013 and June 2014. Sodium chloride injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes for use as a priming solution in hemodialysis procedures and may be used as a diluent for reconstitution of a powdered drug product. Potassium chloride injection is an intravenously administered injectable indicated as a potassium replacement to support nerve conduction, muscle contraction, and prevention of cardiac arrhythmias.
Baxter reports that there have been no reported adverse events associated with this issue to date, and an investigation is underway to determine the root cause.
Source: FDA and Baxter International