The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals. FDA has posted an update on the investigation on its website, which may be found at http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm.
As a reminder, Wallcur’s simulated IV saline solution, Practi-0.9% sodium chloride solution, was shipped to medical clinics, surgical centers, and urgent care facilities in numerous states. So far, more than 40 patients have received infusions of the simulated saline products, and there have been many adverse events associated with these incidents including fever, chills, tremors and headache. Some patients were hospitalized, and there is one death associated with the use of these products; it is not known if this death is directly related to the use of the product. Adverse events have been reported in seven states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado.
To view the full, updated alert on this important situation, visit http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm.