February 04, 2011
American Regent recalls sodium thiosulfate injectionAmerican Regent has initiated a nationwide voluntary recall of one lot of sodium thiosulfate injection. The affected lot is being recalled because some vials of this lot exhibit translucent visible particles consistent with glass delamination. Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.
This recall is for Lot #0056 of sodium thiosulfate injection, USP, 10% (100mg/mL); 10mL single dose vial; NDC# 0517-1019-05; Exp. 1/2012. Healthcare professionals with the recalled product in their possession should stop using it immediately.
Sodium thiosulfate injection is indicated in the treatment of cyanide poisoning.
For more information call (877) 788-3232 or visit www.americanregent.com.