CONTACT: JASON KURTZ 440-201-3668
FOR IMMEDIATE RELEASE — COLUMBUS, OHIO — JULY 14, 2008 — ROXANE LABORATORIES, INC. ANNOUNCED TODAY THAT IT IS CONDUCTING A NATIONWIDE VOLUNTARY RECALL OF TWO MANUFACTURING LOTS OF SODIUM POLYSTYRENE SULFONATE SUSPENSION, USP, 15 G/60 ML UNIT DOSE BOTTLES (NDC 0054-0165-51; LOT 856396A EXP APRIL 2010, AND LOT 856693A EXP MAY 2010). SODIUM POLYSTYRENE SULFONATE SUSPENSION IS USED TO TREAT HYPERKALEMIA (AN ELEVATED BLOOD LEVEL OF THE ELECTROLYTE POTASSIUM).
ROXANE LABORATORIES’ NUMBER ONE PRIORITY IS FOR THE SAFETY OF PATIENTS WHO USE OUR PRODUCTS. A SAMPLE FROM PRODUCT LOT 856396A TESTED POSITIVE FOR A STRAIN OF YEAST, WHICH COULD POTENTIALLY AFFECT IMMUNOCOMPROMISED PATIENTS. ROXANE LABORATORIES BELIEVES THAT THIS MAY BE ATTRIBUTED TO YEAST CONTAMINATION IN ONE LOT OF HIGH-DENSITY POLYETHYLENE BOTTLES RECEIVED FROM A SUPPLIER. THERE ARE VARIOUS MANIFESTATIONS OF YEAST INFECTIONS. THE RISK OF DEVELOPING A YEAST INFECTION DEPENDS ON HOW IMMUNOCOMPROMISED THE PATIENT IS. ADDITIONALLY, THERE ARE A RANGE OF SYMPTOMS IN A YEAST INFECTION FROM THRUSH, SKIN RASH, AND BLOOD INFECTIONS (SEPS
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