PAROEX

Description of Event or Problem

ON 10/28/2020 THE FDA SENT OUT A RECALL FOR SUNSTAR CHLORHEXIDINE GLUCONATE ORAL RINSE DUE TO BACTERIA BURKHOLDERIA LATA. THIS PRODUCT WAS USED AT THE HOSPITAL BETWEEN JULY AND OCTOBER 2020. THERE ARE 11 PATIENTS WHO HAD POSITIVE CULTURES FOR BACTERIA BURKHOLDERIA CEPACIA. EACH OF THE PATIENTS INVOLVED HAD THOROUGH INVESTIGATIONS. PATIENTS WERE TREATED AS APPROPRIATE BY THEIR PHYSICIANS. THE POSITIVE CULTURES WERE REPORTED THROUGH (B)(6) AS WARRANTED AS WELL AS TO THE LOCAL DEPARTMENT OF HEALTH. FDA HAS ALSO BEEN ALERTED. APPROPRIATE PATIENT NOTIFICATION HAS BEEN ACCOMPLISHED. ALL AFFECTED INVENTORY HAS BEEN DISCARDED.