Friday, January 7, 2011

Recall Notice: American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials

On December 23, 2010, American Regent issued a voluntary recall of its Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials due to the possibility of vials containing particulate matter. If use is not discontinued, potential adverse health events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. For this reason, American Regent is undertaking this recall in consideration of the potential for safety issues if any unapproved product is administered to patients. To access recalled product lot numbers, expiration dates, and additional instruction please, reference the Recall Notice in the following link.Click here for more information.