Sagent Announces Temporary Sodium Bicarbonate Injection Import

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Sagent announced that due to the critical shortage of Sodium Bicarbonate Injection in the U.S., it has initiated a temporary importation of a non-FDA approved Sodium Bicarbonate Injection 8.4% (1mEq/mL) from Phebra Pty Ltd., an Australian manufacturer.

Sodium Bicarbonate is an electrolyte replenisher indicated for 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. It is further indicated in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol, in hemolytic reactions requiring alkalinization of the urine to diminish nephrototxicity of blood pigments and in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Phebra's Sodium Bicarbonate Injection (1mEq/mL), is provided only in a single use 10mL vial, whereas Hospira's product is provided in 50mL single-dose vials and syringes. Any unused portion of Phebra's Sodium Bicarbonate Injection (1mEq/mL) should be discarded after a single use.

For more information call (866) 625-1618 or visit http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM334224.pdf.
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