Download NowDecember 29, 2010 — A voluntary recall has been issued for 39 lots of American Regent's sodium bicarbonate injection because of the presence of particulate matter, the US Food and Drug Administration (FDA) announced today.

Introduction of particulate matter into the bloodstream can cause damage to pulmonary vessels, localized swelling, and granuloma formation, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

Hospitals, infusion centers, clinics, and other healthcare facilities should not use any of the recalled lots but should instead quarantine them for return to the company. Customer accounts will be credited for returned product.

Clinicians are reminded that as is standard practice, all parenteral products should be visually inspected whenever possible for particulate matter and discoloration before administration.

Sodium bicarbonate injection is indicated for the treatment of metabolic acidosis associated with severe renal disease, uncontrolled diabetes, circulatory insufficiency caused by shock/dehydration, extracorporeal circulation of blood, cardiac arrest, and severe primary lactic acidosis. Sodium bicarbonate may also be used to treat certain drug intoxications and severe diarrhea.

The recall pertains to lots of sodium bicarbonate 7.5% and sodium bicarbonate 8.4% injection in 50-mL single-dose vials.