December 28, 2010
American Regent recalls sodium bicarbonate 7.5% and 8.4% injectionAmerican Regent announced a nationwide voluntary recall of all unexpired lots of sodium bicarbonate 7.5% and 8.4%, 50mL single dose vial. These lots are being recalled because some vials of these lots contain particulates. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.
Sodium bicarbonate injection is indicated for the treatment of metabolic acidosis, certain drug intoxications (eg, barbiturates), poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Patients, hospitals, infusion centers, clinics and other healthcare facilities should not use the affected lots for patient care and should immediately quarantine any product for return.
For more information call (800) 645-1706 or visit www.americanregent.com.