18 July 2014 | Regulatory | By BioSpectrum Bureau
The lots being recalled were distributed worldwide to customers and distributors between February 2013 and June 2014
Singapore: Baxter is subjected to recall four lots of intravenous (IV) solutions to the hospital/user level that have been found to contain particulate matter identified as cellulosic fibers and/or plastics.
The recall is for Baxter's sodium chloride injection, 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. Another recall is for potassium chloride injection, an intravenously administered injectable indicated as a potassium replacement to support nerve conduction, muscle contraction and prevention of cardiac arrhythmias.
The lots being recalled were distributed worldwide to customers and distributors between February 2013 and June 2014. 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.