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American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials Due to Particulate Matter
Date:12/23/2010

SHIRLEY, N.Y., Dec. 23, 2010 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall to the consumer and user level of ALL unexpired lots of the following products:

Sodium BicaronateInjection,USP, 7.5%, 44.6mEq/50mL, SingleDoseVialNDC# 0517-0639-25andSodium BicaronateInjection,USP, 8.4%, 50mEq50mL, SingleDose VialNDC# 0517-1550-25PLEASE NOTE:  This recall, initiated on December 23, 2010 to the User or Consumer Level is for ALL unexpired lots of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials.  See attached APPENDIX for ALL the lots subject to this voluntary recall.

This voluntary recall was initiated 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.  American Regent is undertaking this recall in consideration of the potential for safety issues if these lots of product are administered to patients.

Sodium Bicarbonate Injection, USP, is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alk
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SOURCE Luitpold Pharmaceuticals, Inc.
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